DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s claim amendments filed 6/15/2026 have overcome the 112 rejections and thus the 112 rejections have been withdrawn.
Applicant's arguments filed 6/15/2026 regarding the prior art rejections have been fully considered but they are not persuasive.
With respect to claim 1, applicant argues on page 9:
“The Examiner mapped Cartledge's disclosure of prompting a user regarding "proper effectiveness for any given therapy" (1 [0035]) to the claimed patient status information. However, Cartledge does not disclose that the patient status information comprises one or more patient reported outcome measures obtained after a surgical intervention has been completed, nor does Cartledge disclose that such outcome measures comprise level of post-interventional pain, mood, medication use, activity level, or amount of sleep. Cartledge's user prompts relate to real-time feedback regarding electrode effectiveness during stimulation-not post-surgical outcome measures of the type now recited in amended claim 1.
The Examiner relied on Cartledge 1 [0035], which states that "inputs derived from a plurality of user data may serve to modify which individual electrodes the generator inputs a greater or lesser signal." The Examiner interpreted this as compiling patient status information into an aggregate set of data. Applicant respectfully disagrees with this interpretation. In context, Cartledge's "plurality of user data" refers to multiple data inputs from a single user's electrode array-i.e., feedback regarding which electrodes in an array are providing effective therapy to that individual patient. This is not the aggregation of patient status information from multiple different patients into a collective dataset representative of therapy outcomes across a patient population.
Amended claim 1 now explicitly recites compiling patient status information "from a plurality of patients undergoing the therapy regimen into an aggregate set of data representative of therapy outcomes across the plurality of different patients." This limitation is entirely absent from Cartledge, which is directed to optimizing electrode selection for a single patient based on that patient's own feedback.”
Regarding the arguments directed towards “post-surgical” usage, the examiner is not persuaded. Rajguru teaches it is known to use such a modification as set forth in [0263] (“The maximal applications of the device include, but are not limited to: Non-invasive stimulation (intermittent or continuous) of the peripheral nervous system for treating chronic pain; stimulation of a nerve for the up- or down-regulation of hormones or cellular proliferation; treatment and/or prevention of atrophy, which would be therapeutic during recovery after an individual sustains a fracture, experiences paralysis of a limb or other body part, or undergoes surgery, such as ACL repair in the knee”) to optimize treatment of individual users in the future (e.g. see [0386]).
Regarding the arguments towards “aggregation of patient status information from multiple different patients into a collective dataset representative of therapy outcomes across a patient population”, the examiner is not persuaded. Rajguru teaches it is known to use such a modification as set forth in [0386] (“The data may also be aggregated (preferably anonymously) to develop treatment algorithms for different patient populations. Effectiveness input from the individual users may also be incorporated into the algorithms, for example pain level over time, comfort level, medication taken etc.”) to optimize treatment of individual users in the future (e.g. see [0386]).
With respect to claim 14, applicant argues on page 13:
“First, there is no articulated motivation to combine all three references. Cartledge is directed to optimizing electrode selection for individual patients. Sharma is directed to population- level pain therapy analytics. Gozani is directed to TENS therapy dosing schedules. The Examiner has not established-and cannot establish-why a person of ordinary skill would look to all three references and combine them in the specific manner required to arrive at the claimed invention.
Second, even assuming arguendo that the individual elements are taught across these references, the claimed invention resides in the specific integration of: (a) time-indexed patient outcome data collected over a dosing schedule longer than one week; (b) aggregation of such data into a first set; and (c) comparison of that first aggregate set with a second user's aggregated data to optimize the therapy regimen. This is a synergistic combination that achieves a result- population-level optimization of post-surgical electrical stimulation therapy using time-indexed outcome data correlated to specific dosing schedules-that is not taught or suggested by any individual reference or obvious sub-combination.
Third, the Examiner's rationale for combining Gozani (providing TENS therapy during the day and throughout the night to more effectively relieve chronic pain) does not logically connect to the aggregation and comparison features of Cartledge and Sharma. There is no nexus between Gozani's dosing motivation and multi-patient data aggregation.”
Regarding the 1st argument, the examiner is not persuaded. In response to the applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, there is teaching, suggestion, or motivation to do so found either in the references themselves as Sharma is cited to provide the predictable results of an enormous amount of information from hundreds or thousands or even millions of individual patients and provides a powerful tool to conduct data analytics (analogous to an automated virtual/crowd-sourced clinical study that constantly gets updated with addition of ever increasing data sets) and customize the pain therapy for individuals either in an automated fashion or through prompt response from the physician (e.g. see [0044]) while Gozani is cited to provide the predictable results of TENS therapy during the day and throughout the night to more effectively relieve chronic pain (e.g. see [0008]) and a “smart” TENS electrode assembly that can uniquely identify its manufacturing origin, materials used, size, shape, and other characteristics that may affect the transmittal of electrical current into the body of the user via the electrode-skin interfaces (e.g. see [0010]). Also, Cartledge, Sharma, and Gozani are all directed towards the highly specific field of transcutaneous electrical nerve stimulation.
Regarding the 2nd argument, the examiner is not persuaded. In response to applicant's argument that “this is a synergistic combination that is not taught or suggested by any individual reference or obvious sub-combination”, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The combined teachings of the references would have suggested to those of ordinary skill in the art is articulated in the rejection below, namely each and every element is taught by the prior art with clearly defined motivations to combine.
Regarding the 3rd argument, the examiner is not persuaded. In the rejection for claim 14, the motivation of providing “TENS therapy during the day and throughout the night to more effectively relieve chronic pain” is cited for the limitation “the therapy regimen comprises applying the therapeutic signal for a series of doses over a first duration of time, wherein each of the doses comprises a second duration of time shorter than the first duration of time, wherein the first duration of time is longer than one week”. Cartledge, Sharma, and Gozani are all directed towards the highly specific field of transcutaneous electrical nerve stimulation, which forms the “nexus” between Cartledge, Sharma, and Gozani.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 8-9, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge et al. (Pub. No.: US 2015/0360030 A1); hereinafter referred to as “Cartledge”, in view of Rajguru et al. (Pub. No.: US 2017/0266443 A1); hereinafter referred to as “Rajguru”.
Regarding claim 1, Cartledge discloses a therapeutic stimulation system for providing a therapy regimen to a patient after a surgical intervention (e.g. see [0035]-[0038]. Note: This is a functional use recitation of a system/device claim. The prior art is capable of and/or configured to perform this functional use limitation), the system comprising: an energy source (e.g. see [0230], “power source circuit”); a housing (e.g. see figure 1 element that houses elements 1-4) comprising a signal generator (e.g. see [0240], “generator”) coupled to the energy source, wherein the signal generator is configured to generate a therapeutic signal and apply the therapeutic signal through a skin of the patient to a target site (e.g. see [0240], figures 4 and 5); a first computer-readable storage device (e.g. see [0231]) configured for downloading onto a device, the first computer-readable storage device storing program instructions that allow one or more processors to instruct the device to prompt a user (e.g. see [0035]-[0036], [0035] states “The user may be prompted by a visual or audible queue, for example, to input whether the user is experiencing proper effectiveness for any given therapy”), when the user is the patient, to enter patient status information during the therapy regimen (e.g. see [0035]-[0036]); and compile the patient status information into an aggregate set of data related to the therapy regimen (e.g. see [0035]-[0036], [0035] states “Additionally, inputs derived from a plurality of user data may serve to modify which individual electrodes the generator inputs a greater or lesser signal. For example, if the generator is sending signals to a electrode array, or to multiple, individual electrodes, user response to effectiveness of therapy may cause the generator to increase the signal to one or more electrodes, decrease to one or other electrodes, or even stop sending a signal completely to one or more electrodes to optimize treatment effect to the structure being targeted”).
Cartledge discloses the claimed invention but is silent as to the patient status information comprises one or more patient reported outcome measures obtained after the surgical intervention has been completed, wherein the one or more patient reported outcome measures comprise post-interventional pain or medication use and compiling the patient status information from a plurality of patients undergoing the therapy regimen into an aggregate set of data representative of therapy outcomes across the plurality of different patients related to the therapy regimen. Rajguru teaches it is known to use such a modification as set forth in [0263], [0386] (Note: [0263] discloses “The maximal applications of the device include, but are not limited to: Non-invasive stimulation (intermittent or continuous) of the peripheral nervous system for treating chronic pain; stimulation of a nerve for the up- or down-regulation of hormones or cellular proliferation; treatment and/or prevention of atrophy, which would be therapeutic during recovery after an individual sustains a fracture, experiences paralysis of a limb or other body part, or undergoes surgery, such as ACL repair in the knee” and [0386] discloses “The data may also be aggregated (preferably anonymously) to develop treatment algorithms for different patient populations. Effectiveness input from the individual users may also be incorporated into the algorithms, for example pain level over time, comfort level, medication taken etc.”) to optimize treatment of individual users in the future (e.g. see [0386]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use both modifications taught by Rajguru in the system of Cartledge, since said modification would provide the predictable results of optimizing treatment of individual users in the future.
Regarding claim 2, Cartledge discloses the computer-readable storage device stores program instructions that allow one or more processors to correlate the aggregate set of data with the therapy regimen (e.g. see [0035]-[0036]).
Regarding claim 3, Cartledge discloses the computer-readable storage device stores program instructions that allow one or more processors to adjust the therapy regimen based on the aggregate set of data (e.g. see [0035]-[0036]).
Regarding claim 8, Cartledge discloses a sensor coupled to the housing and configured to sense a physiological parameter of the patient, wherein the physiological parameter includes one or more of: heart rate (e.g. see [0036]), blood pressure (e.g. see [0036]), blood oxygen (e.g. see [0036], “oxygen saturation”), blood flow (e.g. see [0036], “cardiac output”), gaze (e.g. see [0036], “head position”), and gait (e.g. see [0036] “motion”).
Regarding claim 9, Cartledge discloses the sensor is a motion sensor configured to detect motion of the housing, and the physiological parameter comprises motion data (e.g. see [0036]).
Regarding claim 12, Cartledge discloses one or more electrodes coupled to the signal generator, wherein the energy source is configured to transmit one or more electrical impulses from the electrodes transcutaneously through the outer skin surface to a target location within a spine of the patient (e.g. see [0407]).
Regarding claim 13, Cartledge discloses the computer-readable storage device stores program instructions that allow one or more processors to control the device to prompt the patient to enter the patient status information a period of time after the signal generator has applied the therapeutic signal (e.g. see [0035]).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view of Gozani et al. (Pub. No.: US 2018/0177996 A1); hereinafter referred to as “Gozani”.
Regarding claim 4, Cartledge discloses the therapy regimen comprises applying the therapeutic signal for a duration of time (e.g. see [0233]) but is silent as to the duration is longer than 24 hours. Gozani teaches it is known to use such a modification as set forth in [0008] (Note: Providing treatment during the day and night will read on 24 hours) to provide TENS therapy during the day and throughout the night to more effectively relieve chronic pain (e.g. see [0008]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a duration longer than 24 hours as taught by Gozani in the system of Cartledge, since said modification would provide the predictable results of providing TENS therapy during the day and throughout the night to more effectively relieve chronic pain.
Regarding claim 5, Cartledge discloses the therapy regimen comprises applying the therapeutic signal for a duration of time (e.g. see [0233]) but is silent as to the therapy regimen comprises applying the therapeutic signal for a series of doses over a first duration of time, wherein each of the doses comprises a second duration of time shorter than the first duration of time, wherein the first duration of time is longer than one week. Gozani teaches it is known to use such a modification as set forth in [0008] to provide TENS therapy during the day and throughout the night to more effectively relieve chronic pain (e.g. see [0008]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the therapy regimen comprises applying the therapeutic signal for a series of doses over a first duration of time, wherein each of the doses comprises a second duration of time shorter than the first duration of time, wherein the first duration of time is longer than one week as taught by Gozani in the system of Cartledge, since said modification would provide the predictable results of providing TENS therapy during the day and throughout the night to more effectively relieve chronic pain.
Regarding claim 6, Cartledge discloses the claimed invention except for the aggregate set of data is time-indexed data related to a plurality of data points captured over the first duration of time or the second duration of time. Gozani teaches that it is known to use such a modification as set forth in [0124] to provide a “smart” TENS electrode assembly that can uniquely identify its manufacturing origin, materials used, size, shape, and other characteristics that may affect the transmittal of electrical current into the body of the user via the electrode-skin interfaces (e.g. see [0010]) including time stamps (see [0124]). Gozani further teaches that the total usage interval is updated based on the current “date stamp” and the first-time use “date stamp” (see [0097]). If the total usage interval is greater than an alert threshold, an alert is issued to the user for electrode replacement (see [0097]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use time stamps as taught by Gozani in the system of Cartledge, since said modification would provide the predictable results of a “smart” TENS electrode assembly that can uniquely identify its manufacturing origin, materials used, size, shape, and other characteristics that may affect the transmittal of electrical current into the body of the user via the electrode-skin interfaces.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view of Sharma (Pub. No.: US 2018/0140835 A1).
Regarding claim 10, Cartledge discloses the processor (e.g. see [0230]) but is silent as to the processor is configured to determine usage levels of the signal generator, and further wherein the usage levels are based on a period of time that the therapeutic signal is applied to the skin of the patient. Sharma teaches that it is known to use such a modification as set forth in [0103]-[0104], figure 4 to identify the best possible prescription(s) or dosage of physical medicine such that the therapy administered can lead to efficacious therapy (e.g. see [0104]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to compare the usage levels with the status information as taught by Sharma in the system/method of Cartledge, since said modification would provide the predictable results of identifying the best possible prescription(s) or dosage of physical medicine such that the therapy administered can lead to efficacious therapy.
Regarding claim 11, Cartledge discloses the claimed invention but is silent as to the computer-readable storage device stores program instructions that allow one or more processors to compare the patient status information with the usage levels. Sharma teaches that it is known to use such a modification as set forth in [0103]-[0104], figure 4 to identify the best possible prescription(s) or dosage of physical medicine such that the therapy administered can lead to efficacious therapy (e.g. see [0104]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to compare the usage levels with the status information as taught by Sharma in the system/method of Cartledge, since said modification would provide the predictable results of identifying the best possible prescription(s) or dosage of physical medicine such that the therapy administered can lead to efficacious therapy.
Claim(s) 14-17, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view of Sharma (Pub. No.: US 2018/0140835 A1) and Gozani.
Regarding claim 14, Cartledge discloses the claimed invention (see the rejection for claim 1 above) but is silent as to the computer-readable storage device stores program instructions that allow one or more processors to compare the first aggregate set of data related to the therapy regimen with a second set of aggregated data from a second user to optimize the therapy regimen. Sharma teaches it is known to use such a modification as set forth in [0044] to provide an enormous amount of information from hundreds or thousands or even millions of individual patients and provides a powerful tool to conduct data analytics (analogous to an automated virtual/crowd-sourced clinical study that constantly gets updated with addition of ever increasing data sets) and customize the pain therapy for individuals either in an automated fashion or through prompt response from the physician (e.g. see [0044]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use data from multiple users (e.g. see [0044]) in a patient feedback interface device (e.g. see figure 1 elements 107, 111, 121) as taught by Sharma in the system of Cartledge, since said modification would provide the predictable results of providing an enormous amount of information from hundreds or thousands or even millions of individual patients and provides a powerful tool to conduct data analytics (analogous to an automated virtual/crowd-sourced clinical study that constantly gets updated with addition of ever increasing data sets) and customize the pain therapy for individuals either in an automated fashion or through prompt response from the physician.
Cartledge and Sharma disclose the therapy regimen comprises applying the therapeutic signal for a duration of time (e.g. see [0233]) but are silent as to the therapy regimen comprises applying the therapeutic signal for a series of doses over a first duration of time, wherein each of the doses comprises a second duration of time shorter than the first duration of time, wherein the first duration of time is longer than one week. Gozani teaches it is known to use such a modification as set forth in [0008] to provide TENS therapy during the day and throughout the night to more effectively relieve chronic pain (e.g. see [0008]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the therapy regimen comprises applying the therapeutic signal for a series of doses over a first duration of time, wherein each of the doses comprises a second duration of time shorter than the first duration of time, wherein the first duration of time is longer than one week as taught by Gozani in the system of Cartledge and Sharma, since said modification would provide the predictable results of providing TENS therapy during the day and throughout the night to more effectively relieve chronic pain.
Cartledge and Sharma disclose the claimed invention except for the aggregate set of data is time-indexed data related to a plurality of data points captured over the first duration of time or the second duration of time. Gozani teaches that it is known to use such a modification as set forth in [0124] to provide a “smart” TENS electrode assembly that can uniquely identify its manufacturing origin, materials used, size, shape, and other characteristics that may affect the transmittal of electrical current into the body of the user via the electrode-skin interfaces (e.g. see [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use time stamps as taught by Gozani in the system of Cartledge and Sharma, since said modification would provide the predictable results of a “smart” TENS electrode assembly that can uniquely identify its manufacturing origin, materials used, size, shape, and other characteristics that may affect the transmittal of electrical current into the body of the user via the electrode-skin interfaces.
Regarding claim 15, Cartledge discloses the computer-readable storage device stores program instructions that allow one or more processors to adjust the therapy regimen based on the second set of aggregated data (e.g. see [0035]-[0036]).
Regarding claim 16, Cartledge discloses the therapy regimen comprises parameters of the electrical stimulation device, wherein the parameters comprise one of amplitude, frequency and duration of the electrical impulses (e.g. see [0035]-[0037], especially [0037]).
Regarding claim 17, Cartledge discloses the parameters comprise a duration of time that electrical impulses are applied to the first user by the electrical stimulation device (e.g. see [0035]-[0037], especially [0037]).
Regarding claim 20, Cartledge discloses the claimed invention but is silent as to the therapy regimen is a first therapy regimen and the second set of aggregated data is related to a second therapy regimen provided to the second user, wherein the first therapy regimen comprises different parameters than the second therapy regimen. Sharma teaches it is known to use such a modification as set forth in [0044] to provide an enormous amount of information from hundreds or thousands or even millions of individual patients and provides a powerful tool to conduct data analytics (analogous to an automated virtual/crowd-sourced clinical study that constantly gets updated with addition of ever increasing data sets) and customize the pain therapy for individuals either in an automated fashion or through prompt response from the physician (e.g. see [0044]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use data from multiple therapy regimens with different parameters (e.g. see [0044]) in a patient feedback interface device (e.g. see figure 1 elements 107, 111, 121) as taught by Sharma in the system of Cartledge, since said modification would provide the predictable results of providing an enormous amount of information from hundreds or thousands or even millions of individual patients and provides a powerful tool to conduct data analytics (analogous to an automated virtual/crowd-sourced clinical study that constantly gets updated with addition of ever increasing data sets) and customize the pain therapy for individuals either in an automated fashion or through prompt response from the physician.
Regarding claim 22, Cartledge discloses the computer-readable storage device stores program instructions that allow one or more processors to adjust the therapy regimen (e.g. see [0035]-[0036]).
Claim(s) 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge, Sharma, and Gozani as applied to claims 14 and 22 above, and further in view of Rajguru.
Cartledge, Sharma, and Gozani disclose the claimed invention but are silent as to the second user comprises a population of users and the computer-readable storage device stores program instructions that allow one or more processors to compare the first aggregate set of data related to the therapy regimen with a third set of aggregated data from the population of users to optimize the therapy regimen and the therapy regimen is a recovery protocol for a surgical intervention. Rajguru teaches it is known to use such a modification as set forth in [0263], [0386] (Note: [0263] discloses “The maximal applications of the device include, but are not limited to: Non-invasive stimulation (intermittent or continuous) of the peripheral nervous system for treating chronic pain; stimulation of a nerve for the up- or down-regulation of hormones or cellular proliferation; treatment and/or prevention of atrophy, which would be therapeutic during recovery after an individual sustains a fracture, experiences paralysis of a limb or other body part, or undergoes surgery, such as ACL repair in the knee” and [0386] discloses “The data may also be aggregated (preferably anonymously) to develop treatment algorithms for different patient populations. Effectiveness input from the individual users may also be incorporated into the algorithms, for example pain level over time, comfort level, medication taken etc.”) to optimize treatment of individual users in the future (e.g. see [0386]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use both modifications taught by Rajguru in the system of Cartledge, Sharma, and Gozani, since said modification would provide the predictable results of optimizing treatment of individual users in the future.
Conclusion
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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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