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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The phrases “a first computer-readable program” and “a second computer-readable program” recited in claims 1 and 14 and “a third computer-readable program” recited in claim 14 seems unclear. First, the applicant’s specification uses the language “computer-readable storage device and/or software application” for the “third computer-readable program”. Typically, consistent language should be used between the specification and the claims. The examiner is confused why the claims use “program” but the specification uses “application”. This applies to the first, second, and third computer-readable program. Second, the examiner is confused why the specification uses “storage device” and “software application” interchangeably. These are different elements that have different functions. Third, and most importantly, the examiner is confused why the applicant is claiming 3 different programs rather than just one program as programs/applications are simply computer code. [0090], [0093]-[0096], [0107], [0110]-[0113], [0139]-[0141] all disclose using an application or applications, however, none of the paragraphs disclose an advantage to using multiple programs or applications. The examiner cannot find anything in the specification that discloses there is an advantage to using 3 different programs/applications. [0021] of the applicant’s specification states “In certain embodiments, the second processor may be coupled to the first processor and the system may include a third computer-readable storage device and/or software application that stores program instructions that when executed by the second processor compares the user status data to the usage levels of the device. Alternatively, the third computer-readable storage device may be disposed on the first processor, or a single processor may include all of the computer-readable storage devices”. The fact that all 3 programs/applications/storage devices can run on the same processor further reinforces there is no criticality in the specification that multiple programs provide an advantage. The claim language related to the 3 computer-readable programs is confusing and seems unnecessary. Dependent claims 2-13 and 15-20 are rejected for the same reasons set forth for the independent claims 1 and 14.
In claim 1, it seems unclear what the relationship is between the limitations, “therapy regimen” and “therapy signal.” Dependent claims 2-13 are rejected for the same reasons set forth for the independent claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 8-9, and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cartledge et al. (Pub. No.: US 2015/0360030 A1); hereinafter referred to as “Cartledge”.
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 program (e.g. see [0231]) configured for downloading onto a device, the first computer-readable program being configured 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 a second computer-readable program operable to communicate with the first computer-readable program, wherein the second computer-readable program (e.g. see [0231]. Note: The “program,” “software,” “application,” “computer program,” or “software application” disclosed in [0231] has code which may be subdivided into multiple groups of code which will read on the applicant’s claim language of “a second computer-readable program”) is configured to 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”).
Regarding claim 2, Cartledge discloses the second computer-readable program is configured to correlate the aggregate set of data with the therapy regimen (e.g. see [0035]-[0036]).
Regarding claim 3, Cartledge discloses the second computer-readable program is configured 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 first computer-readable program controls 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 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) 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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view of Rajguru et al. (Pub. No.: US 2017/0266553 A1); hereinafter referred to as “Rajguru”.
Regarding claim 7, 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. Rajguru teaches it is known to use such a modification as set forth in [0263], [0386] 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 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 as 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 .
Claim(s) 10-11, 14-17, and 20 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 second computer-readable program is configured 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.
Regarding claim 14, Cartledge discloses the claimed invention (see the rejection for claim 1 above) and further discloses a third computer-readable program (e.g. see [0231]. Note: The “program,” “software,” “application,” “computer program,” or “software application” disclosed in [0231] has code which may be subdivided into multiple groups of code which will read on the applicant’s claim language of “a second computer-readable program”) but is silent as to the third computer-readable program is configured 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.
Regarding claim 15, Cartledge discloses the third computer-readable program is configured 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.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge and Sharma as applied to claims 14-18 above, and further in view of Gozani.
Regarding claim 18, Cartledge and Sharma disclose 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 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.
Regarding claim 19, 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.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792