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
This action is in reply to the claims filed on 12 February 2026. Claims 1, 3, 12-14, 16, and 19-20 were amended. Claims 1-20 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 February 2026 was filed after the mailing date of the non-final office action on 11 December 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-20 are rejected under 35 USC § 101
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claims 1-20 fall within one or more statutory categories. Claims 1-13 fall within the category of a machine. Claims 14-20 fall within the category of a process.
Step 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1-20 recite an abstract idea. Representative claim 1 recites:
store and maintain a database of device operation and treatment (DOT) information of a neuromodulation device, the database of DOT information being categorized according to a plurality of pre-determined treatment phases and a plurality of pre-determined patient skills or engagement levels with the neuromodulation device, wherein the DOT information comprises (i) patient-releasable device operation and treatment guidance and (ii) patient-authorized neuromodulation device programming capability, and wherein each patient skill or engagement level corresponds to a respective subset of the DOT information; and
determine a treatment phase and a skill or engagement level of the patient at the determined treatment phase using patient state information;
[identify] personalized DOT information that corresponds to the determined treatment phase and the skill or engagement level of the patient; and
provide the personalized DOT information to the patient … .
Therefore, the claim as a whole is directed to “selecting treatment protocol,” which is an abstract idea because it is a method of organizing human activity. “Selecting treatment protocol” is considered to be a method of organizing human activity because it is an example of managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The broadest reasonable interpretation of the claim language includes the interaction between a healthcare provider and a patient. Further, the claims can be considered to be directed to a mental process, because they recite concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the following additional element(s):
a memory device;
a processor;
a user interface;
wherein providing the personalized DOT information to the patient on the user interface comprises selectively enabling, disabling, or constraining user-interface controls for adjusting neuromodulation device operating parameters in accordance with the patient- authorized neuromodulation device programming capability associated with the determined patient skill or engagement level.
The additional elements individually or in combination do not integrate the exception into a practical application. These additional elements merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim 1 is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Claim 1 does not include additional elements, considered individually or in combination, that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element(s), individually and in combination, merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, claim 1 is ineligible.
Dependent claim 2 recites the system of claim 1, wherein:
the processor is further configured to determine a personalized mode of interaction with the patient based on the determined treatment phase and the skill or engagement level of the patient, and
to provide the personalized DOT information to the patient in accordance with the personalized mode of interaction.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 2 is considered to be ineligible.
Dependent claim 3 recites the system of claim 1, wherein:
the patient state information includes text or voice input from the patient via a user-interface device,
wherein the processor is configured to process the text or voice input using natural language processing, and
to determine the treatment phase and the skill or engagement level of the patient using the processed text or voice input.
The additional elements present in this claim merely recites the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). These types of additional elements are not enough to integrate the abstract idea into a practical application, nor do they amount to significantly more than the judicial exception. Accordingly, claim 3 is ineligible.
Dependent claim 4 recites the system of claim 1, wherein:
the processor is configured to: detect a change in treatment phase or a change in patient skills or engagement level;
query the database to update the personalized DOT information; and
provide the updated personalized DOT information to the patient on the user interface.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 4 is considered to be ineligible.
Dependent claim 5 recites the system of claim 1, wherein:
the plurality of pre-determined treatment phases include a plurality of pre-determined temporal phases representing respective times elapsed from a medical event or a predefined milestone.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 5 is considered to be ineligible.
Dependent claim 6 recites the system of claim 1, wherein:
the plurality of pre-determined treatment phases include a plurality of pre-determined stages of patient experience with a neuromodulation therapy.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 6 is considered to be ineligible.
Dependent claim 7 recites the system of claim 1, wherein:
the plurality of pre-determined patient skills or engagement levels include a novice level, an intermediate level, and an expert level,
wherein the processor is configured to determine the skill or engagement level of the patient as one of the novice level, the intermediate level, or the expert level using the patient state information.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 7 is considered to be ineligible.
Dependent claim 8 recites the system of claim 1, wherein:
the plurality of pre-determined patient skills or engagement levels include a plurality of pre-determined patterns of patient interaction with the neuromodulation device to adjust a neuromodulation therapy parameter,
wherein the processor is configured to determine a device interaction pattern of the patient using the patient state information, and query the database to identify therefrom the personalized DOT information that corresponds to the determined treatment phase and the determined device interaction pattern.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 8 is considered to be ineligible.
Dependent claim 9 recites the system of claim 1, wherein:
the patient state information includes patient past interactions with the neuromodulation device,
wherein the processor is configured to track the patient past interactions with the neuromodulation device over time, and to determine the skill or engagement level of the patient based on the tracked patient past interactions.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 9 is considered to be ineligible.
Dependent claim 10 recites the system of claim 1, wherein:
the processor is configured to initiate a diagnostic test of patient performance in interacting with the neuromodulation device, and to determine the skill or engagement level of the patient based on the patient performance in the diagnostic test.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 10 is considered to be ineligible.
Dependent claim 11 recites the system of claim 1, wherein:
the DOT information in a first category of pre- determined treatment phase or pre-determined patient skill or engagement level is different from the DOT information in a second category of pre-determined treatment phase or pre-determined patient skill or engagement level.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 11 is considered to be ineligible.
Dependent claim 12 recites the system of claim 1, wherein:
wherein the pre-determined patient skills or engagement levels include a first skill or engagement level and a second skill or engagement level, the second skill or engagement level representing a lower level of skill or engagement with the neuromodulation device than the first skill or engagement level,
wherein the DOT information corresponding to the first skill or engagement level includes a higher volume or more advanced device and therapy information releasable to the patient than the DOT information corresponding to the second skill or engagement level.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 12 is considered to be ineligible.
Dependent claim 13 recites the system of claim 1, wherein:
wherein the pre-determined patient skills or engagement levels include a first skill or engagement level and a second skill or engagement level, the second skill or engagement level representing a lower level of skill or engagement with the neuromodulation device than the first skill or engagement level,
wherein the patient-authorized neuromodulation device programming capability corresponding to the first skill or engagement level includes more advanced device programming capability authorized to the patient than the patient-authorized neuromodulation device programming capability corresponding to the second skill or engagement level.
This merely further limits the abstract idea of claim 1 discussed above and does not provide further additional elements. Therefore, claim 13 is considered to be ineligible.
Claims 14-20 are parallel in nature to claims 1-3, 5-6, and 11-13. Accordingly claims 14-20 are rejected as being directed towards ineligible subject matter based upon the same analysis above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (U.S. 2019/0126039), hereinafter “Yoo,” in view of Steinke et al. (U.S. 2017/0189689), hereinafter “Steinke.”
Regarding claim 1, Yoo discloses a system for providing customizable interactive healthcare services to a patient in relation to neuromodulation device treatment, the system comprising:
a memory device (See Yoo [0054] the system can include the use of processors and memory.), configured to store and maintain a database of device operation and treatment (DOT) information of a neuromodulation device (See Yoo [0161] system can to access information values stored in memory such as in at least one table that can be related to treatment of a patient such as: parameter values for a stimulation program, treatment credits, activation interval during which the device is permitted to operate, values related to a status or limitations of a prescription of a patient, compliance data and/or criteria of a patient. See also [0150].), the database of DOT information being categorized according to a plurality of pre-determined treatment phases (See Yoo [0073] treatment can be provided in different phases. [0095] adjustments to treatment levels over a time period. [0099] The compliance module may operate to provide different alerting schemes for treatment of different disorders.) and a plurality of pre-determined patient skills or engagement levels with the neuromodulation device (See Yoo [0086] the system can use different compliance criterion for success or failure. [0090]-[0093] the compliance criteria can be measured daily, nightly, weekly, and monthly. [0222] compliance with respect to a digital health regimen that includes being engaged daily or weekly using digital health software programs. [0224] compliance measurement can be relaxed based on patient improvement. [0249] compliance levels with multiple levels based on compliance scores. Accordingly, the use of compliance in this disclosure meets the broadest reasonable interpretation of “engagement levels.” See also [0218].); and
a processor (See Yoo [0054] the system can include the use of processors and memory.) configured to:
determine a treatment phase and a skill or engagement level of the patient at the determined treatment phase using patient state information (See Yoo [0081] system can operate, and work with the other modules of the neurostimulation system, to manage, monitor, track, promote, summarize, analyze, display, report, transmit, process, and alert to, aspects of patient compliance. [0094] compliance criteria directly connected to different treatments. [0153] The strength/duration, strength/number of treatments per unit time, or strength/number of stimulators used to provide stimulation, relationships defined by compliance criteria or other restrictions related to the provision of stimulation (e.g., defined in the payments and permissions module) may be defined in various manners.);
query the database to identify therefrom personalized DOT information that corresponds to the determined treatment phase and the skill or engagement level of the patient (See Yoo [0214] the system is configured to access an established treatment regimen for a patient and to calculate a measurement of compliance for at least one characteristic of the programmable treatment regimen. See also [0216]-[0217]. [0233] the treatment regimen or compliance criterion defined for the provision of neurostimulation can be modified based upon a user's compliance for the provision of medication. See also [0234]. [0239] The system creates a historical record for adjusting a treatment schedule and similarly adjust the compliance rules and criteria used to assess compliance in relation to the schedule or used for selecting compliance criteria from a lookup table. See also [0096]-[0097].); and
provide the personalized DOT information to the patient on a user interface (See Yoo [0207] system can provide user instructions related to actuating the neurostimulator to provide a test stimulation signal and perform assessment and providing stimulation with various protocols. See also [0226]-[0227].).
Yoo does not disclose:
wherein the DOT information comprises (i) patient-releasable device operation and treatment guidance and (ii) patient-authorized neuromodulation device programming capability, and wherein each patient skill or engagement level corresponds to a respective subset of the DOT information;
wherein providing the personalized DOT information to the patient on the user interface comprises selectively enabling, disabling, or constraining user-interface controls for adjusting neuromodulation device operating parameters in accordance with the patient- authorized neuromodulation device programming capability associated with the determined patient skill or engagement level.
Steinke teaches:
wherein the DOT information comprises (i) patient-releasable device operation and treatment guidance and (ii) patient-authorized neuromodulation device programming capability, and wherein each patient skill or engagement level corresponds to a respective subset of the DOT information (See Steinke [0053] Users of the programming device can have different levels of knowledge and expertise with respect to different aspects of programming a neurostimulator. The system can provide different user interfaces for different knowledge or expertise level. This includes a user interface that may be configured for use by the user and/or the patient to adjust the programming as needed when one or more neurostimulation therapies are delivered to the patient. Therefore, the system has different programming interfaces based on the skill level of the user/patient.);
wherein providing the personalized DOT information to the patient on the user interface comprises selectively enabling, disabling, or constraining user-interface controls for adjusting neuromodulation device operating parameters in accordance with the patient- authorized neuromodulation device programming capability associated with the determined patient skill or engagement level (See Steinke [0053] Users of the programming device can have different levels of knowledge and expertise with respect to different aspects of programming a neurostimulator. The system can provide different user interfaces for different knowledge or expertise level. This includes a user interface that may be configured for use by the user and/or the patient to adjust the programming as needed when one or more neurostimulation therapies are delivered to the patient. The user interface provides access to different levels of access to various aspects of neurostimulation programming).
The system of Steinke is applicable to the disclosure of Yoo as they both share characteristics and capabilities, namely, they are directed to the use of neuromodulation treatment devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yoo to include customizable programming and user-interface features as taught by Steinke. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Yoo in order to reduce distraction, ensure accuracy and patient safety, and increase efficiency during programming of a neurostimulator (see Steinke [0053]).
Regarding claim 2, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the processor is further configured to determine a personalized mode of interaction with the patient based on the determined treatment phase and the skill or engagement level of the patient (See Yoo [0153] The strength/duration, strength/number of treatments per unit time, or strength/number of stimulators used to provide stimulation, relationships defined by compliance criteria or other restrictions related to the provision of stimulation (e.g., defined in the payments and permissions module) may be defined in various manners.), and
to provide the personalized DOT information to the patient in accordance with the personalized mode of interaction (See Yoo [0207] system can provide user instructions related to actuating the neurostimulator to provide a test stimulation signal and perform assessment and providing stimulation with various protocols. See also [0226]-[0227].).
Regarding claim 3, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the patient state information includes text or voice input from the patient via a user-interface device (See Yoo [0219] if the video is requested through a voice service (e.g. Alexa) to be viewed by a user, then the system may communicate with the accessory providing the voice service in order register the occurrence of the therapy event. [0237] The voice service technology is also configured to receive a user vocal response.),
wherein the processor is configured to process the text or voice input using natural language processing (See Yoo [0219] if the video is requested through a voice service (e.g. Alexa) to be viewed by a user, then the system may communicate with the accessory providing the voice service in order register the occurrence of the therapy event. [0237] The voice service technology is also configured to receive a user vocal response. This voice services is understood to be using natural language processing in order to convert voice to text for analysis and upload.), and
to determine the treatment phase and the skill or engagement level of the patient using the processed text or voice input (See Yoo [0081] system can operate, and work with the other modules of the neurostimulation system, to manage, monitor, track, promote, summarize, analyze, display, report, transmit, process, and alert to, aspects of patient compliance. [0094] compliance criteria directly connected to different treatments. [0153] The strength/duration, strength/number of treatments per unit time, or strength/number of stimulators used to provide stimulation, relationships defined by compliance criteria or other restrictions related to the provision of stimulation (e.g., defined in the payments and permissions module) may be defined in various manners.).
Regarding claim 4, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the processor is configured to: detect a change in treatment phase or a change in patient skills or engagement level (See Yoo [0239] The system creates a historical record for adjusting a treatment schedule.);
query the database to update the personalized DOT information (See Yoo [0081] system can operate, and work with the other modules of the neurostimulation system, to manage, monitor, track, promote, summarize, analyze, display, report, transmit, process, and alert to, aspects of patient compliance. [0094] compliance criteria directly connected to different treatments. [0153] The strength/duration, strength/number of treatments per unit time, or strength/number of stimulators used to provide stimulation, relationships defined by compliance criteria or other restrictions related to the provision of stimulation (e.g., defined in the payments and permissions module) may be defined in various manners.); and
provide the updated personalized DOT information to the patient on the user interface (See Yoo [0207] system can provide user instructions related to actuating the neurostimulator to provide a test stimulation signal and perform assessment and providing stimulation with various protocols. See also [0226]-[0227].).
Regarding claim 5, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the plurality of pre-determined treatment phases include a plurality of pre-determined temporal phases representing respective times elapsed from a medical event or a predefined milestone (See Yoo [0138] treatment phases can be based on detecting that a certain time has elapsed. See also [0097].).
Regarding claim 6, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the plurality of pre-determined treatment phases include a plurality of pre-determined stages of patient experience with a neuromodulation therapy (See Yoo [0095] the system may prompt the patient to answer questions about symptoms and begin to decrement the frequency of the treatments after a minimum interval only if the patient rating data or patient answers to survey data show improvement (e.g. QOL scores improve over a selected amount). This show of improvement meets the broadest reasonable interpretation of “pre-determined stages of patient experience.”).
Regarding claim 7, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the plurality of pre-determined patient skills or engagement levels include a novice level, an intermediate level, and an expert level, wherein the processor is configured to determine the skill or engagement level of the patient as one of the novice level, the intermediate level, or the expert level using the patient state information 9See Yoo [0128] compliance can be measured by status levels such as “Excellent patient”, “Very good patient”, “Good patient”, “Late Patient”, “Uncooperative Patient”, etc. or are used to calculate one or more scores. This meets the broadest reasonable interpretation of the level labels in this claim.).
Regarding claim 8, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the plurality of pre-determined patient skills or engagement levels include a plurality of pre-determined patterns of patient interaction with the neuromodulation device to adjust a neuromodulation therapy parameter (See Yoo [0086] the system can use different compliance criterion for success or failure. [0090]-[0093] the compliance criteria can be measured daily, nightly, weekly, and monthly. [0222] compliance with respect to a digital health regimen that includes being engaged daily or weekly using digital health software programs. [0224] compliance measurement can be relaxed based on patient improvement. [0249] compliance levels with multiple levels based on compliance scores. Accordingly, the use of compliance in this disclosure meets the broadest reasonable interpretation of “patterns of patient interaction.” See also [0218].),
wherein the processor is configured to determine a device interaction pattern of the patient using the patient state information, and query the database to identify therefrom the personalized DOT information that corresponds to the determined treatment phase and the determined device interaction pattern (See Yoo [0081] system can operate, and work with the other modules of the neurostimulation system, to manage, monitor, track, promote, summarize, analyze, display, report, transmit, process, and alert to, aspects of patient compliance. [0094] compliance criteria directly connected to different treatments. [0153] The strength/duration, strength/number of treatments per unit time, or strength/number of stimulators used to provide stimulation, relationships defined by compliance criteria or other restrictions related to the provision of stimulation (e.g., defined in the payments and permissions module) may be defined in various manners.).
Regarding claim 9, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the patient state information includes patient past interactions with the neuromodulation device, wherein the processor is configured to track the patient past interactions with the neuromodulation device over time, and to determine the skill or engagement level of the patient based on the tracked patient past interactions (See Yoo [0239] The system creates a historical record of patient compliance for adjusting a treatment schedule and similarly adjust the compliance rules and criteria used to assess compliance in relation to the schedule or used for selecting compliance criteria from a lookup table. See also [0096]-[0097].).
Regarding claim 10, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the processor is configured to initiate a diagnostic test of patient performance in interacting with the neuromodulation device, and to determine the skill or engagement level of the patient based on the patient performance in the diagnostic test (See Yoo [0231] the system can calculate a measure of compliance in steps over at least one interval such as during induction (i.e. “a diagnostic test of patient performance in interacting with the neuromodulation device”). See also [0147].).
Regarding claim 11, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the DOT information in a first category of pre- determined treatment phase or pre-determined patient skill or engagement level is different from the DOT information in a second category of pre-determined treatment phase or pre-determined patient skill or engagement level (See Yoo [0156] system includes setting parameter values and operations that contingently occur due to various types and thresholds of non-compliance.).
Regarding claim 12, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the pre-determined patient skills or engagement levels include a first skill or engagement level and a second skill or engagement level, the second skill or engagement level representing a lower level of skill or engagement with the neuromodulation device than the first skill or engagement level (See Yoo [0128] compliance can be measured by status levels such as “Excellent patient”, “Very good patient”, “Good patient”, “Late Patient”, “Uncooperative Patient”, etc. or are used to calculate one or more scores. This meets the broadest reasonable interpretation of the level labels in this claim.),
wherein the DOT information corresponding to the first skill or engagement level includes a higher volume or more advanced device and therapy information releasable to the patient than the DOT information corresponding to the second skill or engagement level (See Yoo [0159] the system can be used to send device update information to a patient who may not be comfortable operating a computer. This is an example of a patient skill level connected to the operation of a more advanced device. See also [0125]).
Regarding claim 13, Yoo in view of Steinke discloses the system of claim 1 as discussed above. Yoo further discloses a system, wherein:
the pre-determined patient skills or engagement levels include a first skill or engagement level and a second skill or engagement level, the second skill or engagement level representing a lower level of skill or engagement with the neuromodulation device than the first skill or engagement level (See Yoo [0128] compliance can be measured by status levels such as “Excellent patient”, “Very good patient”, “Good patient”, “Late Patient”, “Uncooperative Patient”, etc. or are used to calculate one or more scores. This meets the broadest reasonable interpretation of the level labels in this claim.),
wherein the patient-authorized neuromodulation device programming capability corresponding to the first skill or engagement level includes more advanced device programming capability authorized to the patient than the patient-authorized neuromodulation device programming capability corresponding to the second skill or engagement level (See Yoo [0141] user ID and password to determine authorization level and allow for programing and/or setting operating parameters of a neurostimulator. [0149] this can also include screens that allow for programming of compliance criteria such as weekly treatment goals as well as what to do in the case that criteria are met or fail to be met. [0151] defining allowed ranges for stimulation parameters, for registering a neurostimulator to a particular patient.).
Regarding claims 14-20, Yoo discloses the system of claim 1-3, 5-6, and 11-13 as discussed above. Claims 14-20 recite a method that is substantially similar to the method performed by the system of claims 1-3, 5-6, and 11-13. Accordingly, claims 14-20 are rejected based on the same analysis.
Response to Arguments
Applicant's arguments filed 12 February 2026, with respect to the 35 U.S.C. §101 rejection of the claims, have been fully considered but they are not persuasive. First, Applicant argues that the claims are not directed to a method of organizing human activity because they do not require the involvement of a healthcare provider (see Applicant Remarks pages 8-9). This is not persuasive. The broadest reasonable interpretation of the claims includes the interaction between a healthcare provider and a patient. The use of general purpose computer components and functions to replace a healthcare provider does not preclude a finding that the claims are directed to a method of organizing human activity under step 2A Prong One of the analysis. The use of the computer technology is considered under step 2a Prong 2 and step 2B. As presently recited, the activity of the claims are reasonable interpreted to be directed to human activity, i.e. the interaction inherent in the treatment of a patient. The claims are directed to an abstract idea under step 2A Prong One.
Next, Applicant argues that the claims include significantly more than the judicial exception under step 2B (see Applicant Remarks pages 9-11). This is not persuasive. As discussed above, the additional element(s), individually and in combination, merely recite the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or merely include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). This is not enough to amount to significantly more than the judicial exception (or integrate the abstract idea into a practical application). Accordingly, the claims are rejected for being directed to ineligible subject matter.
Applicant's arguments filed 12 February 2026, with respect to the 35 U.S.C. §103 rejection of the claims, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of the newly cited Steinke reference.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Miquel et al. (U.S. 2024/0157158) recites a system and method for optimizing the programing of a neuromodulation device.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN L HANKS whose telephone number is (571)270-5080. The examiner can normally be reached Monday-Friday 8am-5pm.
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/B.L.H./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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