DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
In the response dated June 10, 2026, Applicant amended claims 1, 7, and 21. Claims 1, 3, 5-10, 12-14, 16-18, and 21-24 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 10th, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 30th, 2023 is being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application PCT/EP2022/054980, filed on February 28th, 2022.
Applicant Arguments
Applicant’s arguments were received and will be addressed in the order in which they were presented.
Regarding pages 12-16, Applicants arguments were considered and are persuasive. Examiner withdraws the rejection under 35 U.S.C. 101. Claims 1, 3, 5-10, 12-14, 16-18, and 21-24 recite eligible subject matter under 35 U.S.C. 101.
Regarding pages 16-17, Applicant’s arguments have been considered but are unpersuasive. Applicant argued that the prior art of record does not teach claim 1’s amended claim language of specific treatment parameters. Zhang’s stimulation system creates clinical effects based on sensed parameters that modify electrical stimulation parameters such as “amplitude of a pulse (specified in current or voltage), pulse duration (e.g., in microseconds), pulse rate (e.g., in pulses per second), and parameters associated with a pulse train or pattern such as burst rate (e.g., an “on” modulation time followed by an “off” modulation time), amplitudes of pulses in the pulse train, polarity of the pulses, etc.”, [0077]. Under broadest reasonable interpretation, Examiner maintains that Zhang teaches the Applicant’s amended frequency treatment parameters.
Regarding pages 18, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that Zhang is silent on modifying parameters within a predefined range. Zhang discloses that “programming circuit can check values of the plurality of stimulation parameters against safety rules to limit these values within constraints of the safety rules” [0092]. Under broadest reasonable interpretation, limiting parameters based on safety constraints us consistent with Applicant’s own description of predefining safe range of parameter values.
Regarding pages 18, Applicant’s arguments have been considered but are unpersuasive. Applicant argued that the prior art of record does not teach claim 1’s amended claim language of inputting a health condition of a patient and the expected outcomes into a database. Zhang expressly discloses “implantable stimulator 704 is used as a master database” and that the stored information includes “objective measurements using quantitative assessment of the patient’s symptoms (for example using micro-electrode recording, accelerometers, and/or other sensors), and/or any other information considered important or useful for providing adequate care for the patient”, see [0086]. Zhang also recites that clinical effect scores are “recorded and stored” [0119], which Examiner considers as teaching expected outcomes. Under broadest reasonable interpretation, Zhang’s disclosure encompasses the amended claim language of inputting the conditions, symptoms, and expected outcomes into a patient database.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 12’s “means for receiving a vocal input from the patient” will be interpreted to mean a microphone or any other equivalent structure listed in the specification [page 11].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1,3,5-9,13,14,16-18, 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (US20180272142); hereinafter Zhang.
Regarding claim 1, Zhang teaches a method for programming a neuromodulation device, comprising: (fig. 3 part 302 programming, fig. 4 neuromodulation device)
(a) determining an initial health condition of a patient and inputting the initial health condition of a patient into a patient database; ([0085] “physiological signals include neural and other signals each indicative of a condition of the patient that is treated by the neurostimulation”, and [0086] “implantable stimulator 704 is used as a master database. A patient implanted with implantable stimulator 704 (such as may be implemented as IPG 604) may therefore carry patient information needed for his or her medical care when such information is otherwise unavailable. Implant storage device 746 is configured to store such patient information”);
(b) determining one or more conditions and/or symptoms and/or expected outcomes for the patient ([0115] “the clinical effects (e.g., one or more therapeutic benefits and one or more side effects) can be presented in a form of menus of symptoms shown as sliders and/or have additional weighting options.”) and inputting the expected outcomes into a patient database ([0115] “selectable weights can be applied to the symptoms in calculating a composite therapeutic benefit or side effect score”);
(c) determining initial settings for the neuromodulation device including one or more treatment parameters based on the determined initial health condition of the patient and/or the determined one or more conditions and/or symptoms and/or expected outcomes,([0104] “an initial (the first) stimulation configuration (e.g., with monopolar electrode configuration as shown) is defined by the user (e.g., manually)… the user can grade the first test volume with clinical effect scores… Clinical effect scores (e.g., the therapeutic benefit score and the side effect score) can span multiple symptoms, and/or multiple symptoms may be represented by distinct clinical effect data structures (e.g., dyskinesia and rigidity) ”) and delivering stimulation to the patient based on the determined initial settings; ([0125] “ a plurality of stimulation parameters controlling delivery of the neurostimulation from a stimulation device”);
(d) determining a patient's response with respect to the delivered stimulation based on a patient's feedback on the one or more treatment parameters provided through a user input device ([0122] “and the clinic effects associated with the test volume can be determined based on manually entered information and/or signals sensed from the patient. The manually entered information can include observations by the user and/or feedback provided by the patient”), the method further comprising monitoring the patient to detect the occurrence of deviations in real time ([0085] “Sensing circuit 742, when included and needed, senses one or more physiological signals for purposes of patient monitoring and/or feedback control of the neurostimulation” in real time programming), and/or determining a patient's response with respect to the delivered stimulation based one or more movements and/or gestures of the patient during stimulation delivery that have been detected during stimulation delivery; ([0106]"As shown in FIG. 13, the clinical effects can include those derived from signals sensed from the patient. In various embodiments, the clinical effects can be entered by be user and/or the patient, and/or derived automatically from measurements using various sensors. The sensors can include wearable and/or implantable sensors that senses signals such as movement signal (acceleration), local field potential signals”)
(e) implementing an algorithm that is set to modify, based on the determined patient response, the one or more treatment parameters within a predefined range and determine new settings for the neuromodulation device; ([0063] “the neurostimulation system can allow target volumes of stimulation to be defined and refined by clinical effect mapping, provide guidance to a clinician on optimized program settings based on existing clinical effect maps, algorithm-generated guidance, and/or marked positions, and/or automatically configure stimulation settings (e.g., electrode polarities and fractionalizations), pulse amplitudes, and/or pulse widths from the target volumes”; see also [0092] “programming circuit can check values of the plurality of stimulation parameters against safety rules to limit these values within constraints of the safety rules”)
(f) repeating steps (d) and (e) at predefined time intervals and/or in response to a user input until obtaining one or more treatment parameters settings that are identified as optimal by the algorithm based on the patient's response to stimulation, and ([0122] “At 2982, clinical effects … can be determined based on manually entered information and/or signals sensed from the patient” and [0123] “the target volume can be determined as an optimal balance of the one or more therapeutic benefits and the one or more side effects. In various embodiments, the target volume is determined via an iterative process that repeats steps 2982, 2984, and 2986”)
(g) maintaining the one or more treatment parameters settings identified as optimal by the algorithm,
([0124] “inverse modeling algorithm can generate a stimulation configuration for activating a volume of tissue in the patient”) wherein the one or more treatment parameters include one or more of: neuromodulation frequency ranges; neuromodulation current or voltage ranges; burst modes and patterns; ([0077] “setting modulation parameters can include… setting pulse parameters… pulse parameters include, among other things, the amplitude of a pulse (specified in current or voltage), pulse duration (e.g., in microseconds), pulse rate (e.g., in pulses per second), and parameters associated with a pulse train or pattern such as burst rate (e.g., an “on” modulation time followed by an “off” modulation time), amplitudes of pulses in the pulse train, polarity of the pulses, etc.”) level of patient activity in "on" and "off'' conditions… and/or one or more anticipated activities of the patient. ([0104] “Clinical effect scores … may be represented by distinct clinical effect data structures (e.g., dyskinesia and rigidity)”)
Regarding claim 21, Zhang teaches a system for programming a neuromodulation device, comprising: a neuromodulator device, (fig. 3 part 302 programming, fig. 4 neuromodulation device) and processing module that is configured and adapted to: ([0074] “circuits of neurostimulation 100, including… a microprocessor”)
(a) determine an initial health condition of the patient and input the initial health condition of the patient into a patient database; ([0085] “physiological signals include neural and other signals each indicative of a condition of the patient that is treated by the neurostimulation”, and [0086] “implantable stimulator 704 is used as a master database. A patient implanted with implantable stimulator 704 (such as may be implemented as IPG 604) may therefore carry patient information needed for his or her medical care when such information is otherwise unavailable. Implant storage device 746 is configured to store such patient information”);
(b) determine one or more of conditions, symptoms, and expected outcomes for the patient ([0115] “the clinical effects (e.g., one or more therapeutic benefits and one or more side effects) can be presented in a form of menus of symptoms shown as sliders and/or have additional weighting options.”) and input the one or more of conditions, symptoms and expected outcomes into the patient database; ([0115] “selectable weights can be applied to the symptoms in calculating a composite therapeutic benefit or side effect score”);
(c) determine initial settings for the neuromodulation device including one more treatment parameters based on the determined initial health condition of the patient and/or the one or more of conditions, symptoms, and expected outcomes, ([0104] “an initial (the first) stimulation configuration (e.g., with monopolar electrode configuration as shown) is defined by the user (e.g., manually)… the user can grade the first test volume with clinical effect scores… Clinical effect scores (e.g., the therapeutic benefit score and the side effect score) can span multiple symptoms, and/or multiple symptoms may be represented by distinct clinical effect data structures (e.g., dyskinesia and rigidity) ”) and deliver stimulation to the patient based on the determined initial settings; ([0125] “ a plurality of stimulation parameters controlling delivery of the neurostimulation from a stimulation device”);
(d) determine a patient's response with respect to the delivered stimulation; ([0106]"As shown in FIG. 13, the clinical effects can include those derived from signals sensed from the patient. In various embodiments, the clinical effects can be entered by be user and/or the patient, and/or derived automatically from measurements using various sensors. The sensors can include wearable and/or implantable sensors that senses signals such as movement signal (acceleration), local field potential signals”)
(e) implement an algorithm that is set to modify, based on the determined patient's response, the one or more treatment parameters within a predefined range and determine new settings for the neuromodulation device; ([0063] “the neurostimulation system can allow target volumes of stimulation to be defined and refined by clinical effect mapping, provide guidance to a clinician on optimized program settings based on existing clinical effect maps, algorithm-generated guidance, and/or marked positions, and/or automatically configure stimulation settings (e.g., electrode polarities and fractionalizations), pulse amplitudes, and/or pulse widths from the target volumes”; see also [0092] “programming circuit can check values of the plurality of stimulation parameters against safety rules to limit these values within constraints of the safety rules”)
(f) repeat steps (d) and (e) at predefined time intervals and/or in response to a user input until obtaining one or more treatment parameters settings that are identified as optimal by the algorithm, based on the patient's response to stimulation, and ([0122] “At 2982, clinical effects … can be determined based on manually entered information and/or signals sensed from the patient” and [0123] “the target volume can be determined as an optimal balance of the one or more therapeutic benefits and the one or more side effects. In various embodiments, the target volume is determined via an iterative process that repeats steps 2982, 2984, and 2986”)
(g) maintain the one or more treatment parameters settings identified as optimal by the algorithm, ([0124] “inverse modeling algorithm can generate a stimulation configuration for activating a volume of tissue in the patient”)
wherein the one or more treatment parameters include one or more of: neuromodulation frequency ranges; neuromodulation current or voltage ranges; burst modes and patterns; ([0077] “setting modulation parameters can include… setting pulse parameters… pulse parameters include, among other things, the amplitude of a pulse (specified in current or voltage), pulse duration (e.g., in microseconds), pulse rate (e.g., in pulses per second), and parameters associated with a pulse train or pattern such as burst rate (e.g., an “on” modulation time followed by an “off” modulation time), amplitudes of pulses in the pulse train, polarity of the pulses, etc.”) level of patient activity in "on" and "off'' conditions… and/or one or more anticipated activities of the patient. ([0104] “Clinical effect scores … may be represented by distinct clinical effect data structures (e.g., dyskinesia and rigidity)”)
Regarding claim 3, Zhang teaches all of the limitations of claim 1. Zhang also teaches recording brain signals of the patient during stimulation, and the patient's response with respect to the delivered stimulation is determined based on the recorded brain signals. ([0106] “clinical effects can be entered by be user and/or the patient, and/or derived automatically from measurements using various sensors. The sensors can include … local field potential signal, electroencephalogram (EEG)”)
Regarding claim 5, Zhang teaches all of the limitations of claim 1. Zhang also teaches organizing the determined one or more conditions and/or symptoms and/or expected outcomes for the patient according to predefined criteria of priority. ([Fig. 17] and [0115] “a clinical effects console 1768 …can be presented in a form of menus of symptoms shown as sliders and/or have additional weighting options. selectable weights can be applied to the symptoms in calculating a composite therapeutic benefit or side effect score”)
Regarding claim 7, Zhang teaches all of the limitations of claim 1. Zhang also teaches the one or more treatment parameters further include electrode selection ([0077] “setting modulation parameters can include, among other things, selecting the electrodes or electrode combinations used in the stimulation”)
Regarding claim 8, Zhang teaches all of the limitations of claim 1. Zhang also teaches wherein the user input device is a portable or wearable device. ([0088] “an external programming device 802 of an implantable neurostimulation system”; see also [0106] “The sensors can include wearable and/or implantable sensors”)
Regarding claim 9, Zhang teaches all of the limitations of claim 1. Zhang also teaches wherein the user input device includes a touch-sensitive display that is configured and adapted to display a user interface including a plurality of selectable options, and allow selection of one or more of the displayed selectable options through a touch input. ([0093] “user input device 858 may include any type of user input devices that supports the various functions discussed in this document, such as touchscreen, keyboard, keypad, touchpad, trackball, joystick, and mouse” and [0108] “a “Guidance?” button allows the user to obtain a recommended volume under the manual mode”)
Regarding claim 13, Zhang teaches all of the limitations of claim 1. Zhang also teaches wherein the method further comprises the following steps: collecting information on environmental and/or physiological conditions and/or one or more movements and/or gestures of the patient in real time, and processing the collected information for use by the algorithm in determining the new settings for the neuromodulation device. ([0106] “As shown in FIG. 13, the clinical effects can include those derived from signals sensed from the patient… the clinical effects are the data used to determine the new settings for the neuromodulation device… The sensors can include… movement signal (acceleration), local field potential signal, electroencephalogram (EEG) signal (e sensed using a wearable sensor), single unit activity signal (e.g., sensed using an implantable sensor), electromyogram (EMG) signal (e.g., for indicating rigidity and/or tremor, sensed using a wearable sensor”)
Regarding claim 14, Zhang teaches all of the limitations of claim 13. Zhang also teaches wherein said information on environmental and/or physiological conditions and/or one or more movements and/or gestures of the patient is collected through sensor means and/or a camera and/or a microphone or voice command module, wherein said sensor means and/or camera are embedded in a portable device of the patient. ([0106] “the sensors can include wearable and/or implantable sensors that senses signals such as movement signal (acceleration)”)
Regarding claim 22, Zhang teaches all of the limitations of claim 14. Zhang also teaches the system further comprises: a user input device configured and adapted to allow a patient to provide feedback on one or more treatment parameters, wherein the processing module is further configured and adapted to: receive and process a patient's feedback on the one or more treatment parameters, provided through the user input device. ([0065] “the patient can be allowed to adjust his or her treatment using system to certain extent, such as by adjusting certain therapy parameters and entering feedback and clinical effect information.” Occurs via the user interface)
Regarding claim 23, Zhang teaches all of the limitations of claim 14. Zhang also teaches the user input device is a portable or wearable device, ([0088] “an external programming device 802 of an implantable neurostimulation system”; see also [0106] “The sensors can include wearable and/or implantable sensors”) including a touch-sensitive display that is configured and adapted to display a user interface including a plurality of selectable options, and allow selection of one or more of the displayed selectable options through a touch input. ([0093] “user input device 858 may include any type of user input devices that supports the various functions discussed in this document, such as touchscreen, keyboard, keypad, touchpad, trackball, joystick, and mouse” and [0108] “a “Guidance?” button allows the user to obtain a recommended volume under the manual mode”)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Jiang et al (US 20160045751 A1); hereinafter Jiang.
Regarding claim 10, Zhang teaches all of the limitations of claim 1. Zhang does not explicitly teach, as taught by Jiang wherein the method further comprises the step of displaying a plurality of selectable options on the touch-sensitive display at predefined time intervals, wherein the displayed plurality of selectable options is color-coded. ([0115] “CP 60 may display the suitability of each electrode for neurostimulation in the electrode status display 64 by a color coding or other suitable indicator”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the system of Zhang to make the selectable options color coded, as taught by Jiang, for the purposes of “communicat[ing] to the clinician that the lead needs to be advanced” into an optimal state [0115]. Adjusting displays to color code information is use of a known technique to a known device. Many graphical user interfaces of medical devices use color coded screen selection and even outside of medical devices, and it is uncommon for user interfaces to avoid color-coding options on color enabled screens.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Vera-Portocarrero (US 20200368518 A1); hereinafter Vera.
Regarding claim 12, Zhang teaches all of the limitations of claim 8. Zhang does not explicitly teach, as taught by Vera wherein the user input device further includes means for receiving a vocal input from the patient. ([0055] “UI 18 may further include a softkeys, hard keys (e.g., physical buttons), lights, a speaker and microphone for voice commands”). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the system of Zhang with a reasonable expectation of success by adding a microphone, as taught by Vera, for the purpose of improve user interaction with patients struggling with mobility. Zhang would have used this a known technique to add a conventional microphone for improvement to yield similar results. Voice controlled/activated medical devices are common in the art and implementing voice control into this particular device is an obvious improvement, especially because potential patients of this device may have movement disorders that preclude them from using a touch-based user interface.
Claims 6, 16, 17, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Offutt et al (US20210316145A1); hereinafter Offutt.
Regarding claim 6, Zhang teaches all of the limitations of claim 1. Zhang does not explicitly teach, as taught by Offutt the initial settings for the neuromodulation device are determined based on collected data from one or more groups of patients having identical or similar health conditions than the patient subject to treatment. ([0095] “circuitry 228 may compare the first information of the patient to first information of other patients in the population-informed information in the database… server 26 may utilize the first information as a tool for patient selection. Server 26 may utilize first information to determine a recommended therapy approach including an implant target, initial programming characteristics”) It would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date to modify the system of Zhang by explicitly categorizing patients in a database, as taught by Offutt, for the purpose of selecting data from similarly situated patient populations. Zhang would have come across Offutt while seeking solutions for personalized stimulation therapy for patient populations, as Offutt teaches accessing a database can help “determine whether patient 14 is a candidate for neurostimulation based on the first information” ([0095]).
Regarding claim 16, Zhang teaches all of the limitations of claim 1. Zhang does not explicitly teach, as taught by Offutt searchable database with information about a population of patients. Offutt teaches wherein the method further comprises the following steps: storing, on a database, data regarding different groups of patients ([0092] “the population-informed information may be stored in a database 234”), each of the groups including patients having similar or identical health and therapy conditions ([0095] “determine whether other patients with similar first information were successfully treated as they moved along the care pathway from baseline to trial to implant”); processing said data according to predefined criteria ([0095] “processor circuitry 228 of server 26 determine whether patient 14 is a candidate for neurostimulation based on the first information. For example, processor circuitry 228 may compare the first information of the patient to first information of other patients in the population-informed information in the database 234 in memory 226” where comparison comprises a threshold), wherein the predefined criteria include criteria for selecting initial settings for the neuromodulation device for patients having similar or identical health and therapy conditions ([0097] “the population-informed data may be anonymized data stored in a database 234 on server 26 or accessible by server 26. For example, server 26 may determine different initial stimulation program settings for patients with a particular disease”), and defining the initial settings of the neuromodulation device and the algorithm based on data of a group of patients having similar or identical health and therapy conditions than the patient subject to treatment ([0095] “Server 26 may utilize first information to determine a recommended therapy approach including an implant target, initial programming characteristics and behavioral recommendations”).
Regarding claim 17, Zhang teaches all of the limitations of claim 16. Zhang does not explicitly teach, as taught by Offutt the method further comprises the following step: setting one or more filters in said database to allow an operator to find a group of patients having similar or identical health and therapy conditions than the patient subject to treatment based on the determined initial health condition of the patient and/or the determined one or more conditions and/or symptoms and/or expected outcomes for the patient. ([0095] “processor circuitry 228 may compare the first information of the patient to first information of other patients in the population-informed information in the database”)
Regarding claim 24, Zhang teaches all of the limitations of claim 21. Zhang does not explicitly teach, as taught by Offutt the system further comprises a database, for storing data regarding groups of patients ([0092] “the population-informed information may be stored in a database 234”), each group including patients having similar or identical health and/or therapy conditions. ([0095] “circuitry 228 may compare the first information of the patient to first information of other patients in the population-informed information in the database… server 26 may utilize the first information as a tool for patient selection. Server 26 may utilize first information to determine a recommended therapy approach including an implant target, initial programming characteristics”)
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mustakos et al. (Pat. 12582825) uses a translator that automatically converts one neuromodulation program into another polarity based on a triggering event.
Haddock et al. (Pat. 12370365) trains a patient-specific model using sensed spinal electrical activity gathered while the patient is in different postures and stimulation levels
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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