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 .
Claims 1, 3-4, 7-8, 10, 12, 14, 16 and 17-19 have been amended. Claims 9 and 13 are cancelled. Claims 21-22 are new. Claims 1-8, 10-12 and 14-22 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/16/2026 has been entered.
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 1-8, 10-12 and 14-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-8, 10-12, 14-15 and 21 are drawn to a method for improving a medical system to improve patient satisfaction, which is within the four statutory categories (i.e. process). Claim 16 is drawn to a non-transitory medium for improving a medical system to improve patient satisfaction which is within the four statutory categories (i.e. manufacture). Claims 17-20 and 22 are drawn to a system for determining health-related information for a patient and deliver a neuromodulation therapy which is within the four statutory categories (i.e. machine).
Claims 1-8, 10-12, 14-15 and 21 (Group I) recite a method for improving a medical system to improve patient satisfaction, the medical system including a patient system, the patient system including a patient device with a user interface and a therapy-delivery device configured to deliver a neuromodulation therapy to a patient, the patient system being configured to determine health-related information for the patient, wherein the method comprises:
using the patient system (MPEP § 2106.05(g), apply it) to determine the health-related information for the patient and deliver the neuromodulation therapy to the patient;
identifying, from the health-related information, at least one of a plurality of issues that may be adversely affecting the patient satisfaction for the patient system, wherein the plurality of issues include improper interaction with the patient system or include stimulation is either ineffective for the neuromodulation therapy or has adverse side effects, wherein the plurality of issues corresponds to stored patient assistance data, the stored patient assistance data including educational material for educating the patient on how to interact with the patient system or troubleshooting recommendations for the patient to troubleshoot the stimulation when the stimulation is determined to be ineffective or to have adverse side effects, wherein identifying the at least one of the plurality of issues is performed automatically by the patient system by sensing device-sensed parameters including at least one of battery voltage, charging rate, impedance measurements, device state timing, a schedule on the therapy-delivery device that was added but is not used combined with poor pain outcomes from the neuromodulation therapy, or stimulation efficacy data comprising at least one of pain outcome data, stimulator usage data, or program usage data derived from the health-related information; and
sending the patient assistance data, that corresponds to the at least one of the plurality of issues, to the user interface of the patient device within the patient system (MPEP § 2106.05(g), apply it), wherein the patient assistance data causes the user interface (MPEP § 2106.05(g), apply it) to present at least one of a training video, troubleshooting recommendations, or a program change recommendation specific to the identified issue.
Claim 17 further recites a therapy-delivery device configured to deliver the neuromodulation therapy to the patient (MPEP § 2106.05(g), apply it); a patient device having a user interface (MPEP § 2106.05(g), apply it), storage for storing patient assistance data (MPEP § 2106.05(g), apply it); and a satisfaction monitor (MPEP § 2106.05(g), apply it).
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the method of organizing human activity are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 16 and 17-20 and 22 is similar to the abstract idea for Claims 1-8, 10-12, 14-15 and 21 (Group I), because the claims are merely directed at different statutory categories.
Dependent Claims 2-8, 10-12, 14-15 and 18-22 include other limitations, for example Claims 2 and 18 recite wherein: the plurality of issues includes the improper patient interaction with the patient system; and the educational material includes the educational material for educating the patient how to interact with the patient system, Claims 3 and 19 recite wherein the improper patient interaction includes improper use of the patient device, and the educational material includes a training video for how to use the patient device, wherein the patient assistance data causes the user interface to automatically present the training video without clinician intermediation, Claim 4 recites wherein the improper patient interaction includes improper charging of the therapy-delivery device, and the educational material includes a training video for how to recharge the therapy-delivery device, Claim 5 recites wherein the health-related information used to identify the improper charging of the patient device includes: consistently low battery voltage; slow charging rates; insufficient maximum battery voltage; high thermistor values during charging; low charge current; device state timing, wherein the device state includes device ON, device OFF, or device hibernation; or topic modeling of free text to detect the improper charging within the free text, Claims 6 and 20 recite wherein the improper patient interaction includes a problem with changing neurostimulation programs, the educational material includes a training video for how to change the neurostimulation programs, and the health-related information used to identify the problem with changing neurostimulation programs includes: poor pain outcomes from neuromodulation therapy and no neurostimulation programming changes; stimulator usage; program usage; or topic modeling of free text to detect the problems with changing neurostimulation programming changes within the free text, Claim 7 recites wherein the improper patient interaction includes a problem with changing or starting neurostimulation schedules, and the health-related information used to identify the problem with changing or starting neurostimulation schedules includes poor pain outcomes from the neuromodulation therapy combined with a determination that a schedule on the therapy-delivery device was added but is not used, Claim 8 recites wherein the improper patient interaction includes at least one of a failed data upload or an improper connection or recharging of a wearable device, the patient assistance data includes a training video for the patient interaction, and the health-related information used to identify the improper patient interaction includes at least one of a lack of uploaded data from the patient system, app logs showing failed data uploads, a lack of uploaded wearable device data, consistently low wearable device battery levels, or topic modeling of free text to detect the improper patient interaction, wherein the patient assistance data causes the user interface to transition from a therapy control display state to a patient assistance display state presenting the training video, and wherein the user interface returns to the therapy control display state after the patient interacts with the patient assistance data, Claim 10 recites wherein the plurality of issues includes the stimulation that is either ineffective or has adverse side effects, and the method includes sending troubleshooting recommendations for the patient to troubleshoot the stimulation when the stimulation is determined to be ineffective or to have adverse side effects, wherein the troubleshooting recommendations cause the user interface to present patient-directed troubleshooting steps specific to the identified stimulation issue, Claim 11 recites further comprising alerting a clinician or representative that the neuromodulation therapy should be reprogrammed if the troubleshooting is not successful in providing efficacious stimulation without the adverse side effects, Claim 12 recites wherein the therapy-delivery device is an implantable neurostimulator electrically connected to one or more leads carrying electrodes positioned proximate to neural tissue of the patient (MPEP § 2106.05(g), apply it), and wherein the health-related information used to determine that the stimulation is ineffective or has adverse side effects includes at least one of: impedance measurements from the one or more electrodes of the therapy-delivery device indicating that at least one impedance measurement exceeds a stored impedance threshold; topic modeling of free text to detect that the stimulation is ineffective or has adverse side effects; or sending a campaign to the patient device to have the patient determine overlap between stimulation and pain area, and suggesting a program change or alerting a clinician or a representative that the neuromodulation therapy should be reprogrammed if the stimulation does not adequately overlap the pain area, Claim 14 recites further comprising sending a campaign to the patient device to have the patient measure at least one impedance of the therapy-delivery device, comparing the measured at least one impedance to a threshold, and alerting a clinician or a representative that the neuromodulation therapy should be reprogrammed when the measured at least one impedance exceeds the threshold, Claim 15 recites determining if the patient considers the stimulation to be too strong or too weak, suggesting amplitude changes if the patient considers the stimulation to be too strong or too weak, and alerting a clinician or a representative that the neuromodulation therapy should be reprogrammed if the amplitude changes do not remedy the stimulation that is too strong or too weak, Claim 21 recites wherein identifying the at least one of the plurality of issues includes automatically monitoring, by the patient system without clinician intermediation, the device-sensed parameters over a period of time and comparing the device-sensed parameters to stored thresholds corresponding to the plurality of issues, and wherein the patient assistance data causes the user interface to transition from a therapy control display state to a patient assistance display state presenting the at least one of the training video, troubleshooting recommendations, or program change recommendation, and wherein the user interface returns to the therapy control display state after the patient interacts with the patient assistance data, and Claim 22 recites wherein the therapy-delivery device is an implantable neurostimulator electrically connected to one or more leads carrying electrodes positioned proximate to neural tissue of the patient, and wherein the satisfaction monitor is configured to automatically monitor the device-sensed parameters over a period of time without clinician intermediation and compare the device-sensed parameters to stored thresholds corresponding to the plurality of issues (MPEP § 2106.05(g), apply it), but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1, 16 and 17.
Furthermore, Claims 1-8, 10-12 and 14-22 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of patient system, user interface, a therapy-delivery device. storage and satisfaction monitor, which amounts to merely invoking a computer or other machinery as a tool to perform the abstract idea, e.g. see paragraphs [0005], [0043], [0099], [0101], [0103-0104], [0136] and [0140] of the present Specification, see MPEP 2106.05(f); and
generally link the abstract idea to a particular technological environment or field of use, see MPEP 2106.05(h)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0043], [0099], [0101], [0104], [0136] and [0140] of the Specification discloses that the additional elements (i.e. patient system, patient device, user interface, storage and satisfaction monitor) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry or other machinery merely used as a tool to perform an existing process (i.e. healthcare).
The dependent claims include other limitations, but they merely further limit the abstract idea and do not contain any additional elements beyond those recited in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-8, 10-12 and 14-22 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free from Prior Art
The closest prior art of record, including Zenisek (U.S. Pub. No. 2022/0230743 A1) and Wagner (WO 2024/086537 A1), do not disclose or render obvious the claimed invention of independent claims 1, 16 and 17. Specifically, the prior art of record, does not disclose or render obvious “wherein identifying the at least one of the plurality of issues is performed automatically by the patient system by sensing device-sensed parameters including at least one of battery voltage, charging rate, impedance measurements, device state timing, a schedule on the therapy-delivery device that was added but is not used combined with poor pain outcomes from the neuromodulation therapy, or stimulation efficacy data comprising at least one of pain outcome data, stimulator usage data, or program usage data derived from the health-related information; and sending the patient assistance data, that corresponds to the at least one of the plurality of issues, to the user interface of the patient device within the patient system, wherein the patient assistance data causes the user interface to present at least one of a training video, troubleshooting recommendations, or a program change recommendation specific to the identified issue” in combination with the other limitations.
Response to Arguments
Applicant's arguments filed 03/16/2026 have been fully considered.
Claim Objections
The previous claim objections have been withdrawn in view of the amendments.
The Rejection of Claims Under § 101
Regarding Step 2A, Prong One, Applicant asserts that the claims are drawn to a technical process, not an abstract idea because the claim requires “automatically identif[ying] defined technical failure modes from those parameters, and in response causes the user interface to present specific, pre-stored remediation content (a training video, troubleshooting recommendations, or a program change recommendation) specific to the identified issue (Remarks, page 10).” Examiner disagrees that this a technical problem with a technical solution. Outputting a video or other educational material to instruct the patient on how to correct the identified issue is abstract. The claims requiring collecting the data, which is analyzed, and based on that analysis, specific educational material is presented to the patient. The instant claims are automating the troubleshooting with the patient and their interaction with the therapy-delivery device. The instant specification supports this position in [0006] “[r]emote patient monitoring platforms allow clinicians, device reps, and patient care to monitor large patient populations. However, it may be difficult and time consuming to go through every patient to determine if they need help. It is desired to improve the management and assistance provided to remotely managed patient populations.”
Applicant asserts that the claimed invention in similar to Example 37 stating “provides a specific improvement over prior systems, resulting in an improved user interface for electronic devices (Remarks, page 10).” Here, the user interface is not improved by the claimed invention. It is recited at an “apply it” level, and it is not improved by displaying different educational material. In Example 37, the icons on the user interface were rearranged to improve the actual use of computer by putting the most used program icons closer to the start icon. Here, the user interface is not improved by telling the user the correct way to use the patient device. For example, if the educational material is a video on how to use the patient device (such as recited in claim 3) or how to recharge the therapy-delivery device properly (such as recited in claim 4), it is not improving the patient device itself.
Examiner maintains that the display of information to the user is part of the abstract idea (excluding the actual user interface of the patient device). There is no technical problem with the user interface. This information could be given to the patient on paper (for instance, instructions utilizing screenshots of a video) and it would have the same result. There does not appear to be a technical problem with displaying information, so even if the solution was technical, it would not rise to the level of a practical application.
While the educational material may tell the user how to “fix” the issue, there is nothing recited in the claim that actually changes the operational state of the patient device or the therapy-delivery device.
Applicant asserts that the “specification identifies the technical problem: remote patient monitoring platforms manage large patient populations, but ‘it may be difficult and time-consuming to go through every patient to determine if they need help (Remarks, page 14).’" Examiner maintains that this is not technical in nature as the claims are merely automating assistance usually provided by a device rep or a clinician. Changing what is displayed to the user on their mobile device does not result in an improvement to the patient device or the therapy delivery device.
Regarding Step 2B, Applicant argues that the additional elements are not well-understood, routine, and conventional because the “Examiner has cited no prior art, industry standards, or other evidence to establish that this pipeline was conventional” and that the “Examiner bears the burden under Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018), to provide evidence that the ordered combination of elements was well-understood, routine, and conventional, and the cited specification paragraphs describing individual device types do not meet that burden (Remarks, page 14).” Examiner did not assert any of the additional elements as extra-solution activity. A factual determination is required to support a conclusion that an additional element (or combination of additional elements) is well-understood, routine, conventional activity. Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018). As the additional elements are all recited at the “apply it” level, there is nothing that required citing to Berkheimer evidence. The devices used are not improved by the claimed invention, and are merely used as intended. Contrast with Thales Visionix, wherein the particular configuration of inertial sensors and the particular method of using the raw data from the sensors was more than simply applying the judicial exception (a law of nature). See MPEP § 2106.05(f).
Examiner maintains that claims 16 and 17 are ineligible for the same reasons as claim 1.
With respect to the dependent claims, they do not include any additional elements beyond those included in the dependent claims and further limit the abstract idea found in the independent claims 1, 16 and 17. These additional elements are recited at the “apply it” level as discussed in the rejection and do not result in a practical application of the recited abstract idea or significantly more than the recited abstract idea.
Examiner maintains that claims 1, 16 and 17, and their respective dependents recite ineligible subject matter, and therefore remain rejected under 35 U.S.C. § 101.
The Rejection of Claims Under § 102
Applicant’s arguments regarding the art rejection have been considered but are moot in view of the withdrawn rejection as a result of the amendments.
The Rejection of Claims Under § 103
Applicant’s arguments regarding the art rejection have been considered but are moot in view of the withdrawn rejection as a result of the amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached on (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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