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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/2/2025 has been entered.
Response to Arguments
Applicant's arguments filed 3/29/2026 have been fully considered but they are not persuasive.
Applicant argues on page 2: “The Howser reference does not differentiate between "therapy session time intervals" and "calendar time intervals" as is necessary to the subject Application system. Thus, there is no indication in the Howser reference of any processor evaluating and comparing a therapy session time interval as well as a calendar time interval for some prescribed therapy regimen.”
The examiner is not persuaded. [0014] of Howser discloses “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment” and [0022] discloses “As the patient uses the transcutaneous electrical stimulator 20, patient data or user information (e.g., amplitude settings, time used, date used, total treatment time, mode of treatment) is generated and stored in the transcutaneous electrical stimulator 20”. Time in combination with date will read on “calendar time interval” and “calendar time intervals independent of a set of therapy session neurostimulator operational times”.
Regarding the arguments directed towards the secondary reference, the examiner has replaced the Hartley reference with Southwell et al., which is more relevant as it is directed towards transcutaneous electrical stimulation and is displayed in calendar form. The examiner believes the Southwell reference predates all of the calendar and compliancy data per the “Continuity Data” section below. Regarding the Hartley reference, the examiner is keeping the reference as a backup rejection in case it is needed later in prosecution (for example if the applicant is able to prove earlier continuity data support for the compliance and/or calendar limitations).
Regarding the arguments directed towards the Cazares et al. reference and claims 11-14, the examiner is not persuaded. The applicant argues on page 4 “The Cazares reference system is directed to a different technology, a different set of elements for different objectives than the subject Application system and has nothing to do with any therapy sessions as is necessary to the subject Application system”.
In response to applicant's argument that Cazares is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the prior art (Cazares) is 1) in the field of the inventor’s endeavor and 2) reasonably pertinent to the particular problem with which the inventor was concerned. Cazares is directed towards a system for addressing patient compliance with a prescribed treatment as [0101] states “Measurements of patient compliance may provide a general indication of how closely a patient follows a physician's or clinician's direction or instruction”. The applicant’s independent claim is likewise directed towards a medical device for “determining patient compliance with said prescribed treatment values”.
Continuity Data
The calendar limitations are supported through provisional application 62/375,898 with a priority date of 8/16/2016. The CIP’s that split off 15/678,824 (15/160,585 and 15/439,415) do not appear to contain the calendar limitations (or figures 7A and 7B which encompass the calendar subject matter). The compliancy limitations appear to be supported through provisional 62/165,037 with a priority date of 5/21/2015. CIP 14/553,427 does not appear to contain the compliancy limitations.
Claim Rejections - 35 USC § 103 (primary rejection)
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 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, 8-10, 12-13, 15-17, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howser et al. (Pub. No.: US 2004/0204962 A1); hereinafter referred to as “Howser”, in view of Southwell et al. (International Publication Number: WO 2015/051406 A1); hereinafter referred to as “Southwell” (Note: The priority data for this is International Filing Date of 10/10/2014 which claims priority to the Australian application filed 10/11/2013).
Regarding claim 1, Howser discloses a neurostimulation system (e.g. see figure 1 element 10) for operating upon and displaying usage data corresponding to providing therapy operations with a neurostimulation therapy system comprising: (a) a neurostimulation device (e.g. see figure 1 element 20) including a neurostimulator adapted to apply an electrical or magnetic signal to a patient's body (e.g. see [0016]-[0018]) during at least one therapy session in accordance with a prescribed regimen (e.g. see [0018]), said operation of said neurostimulator during said at least one therapy session defining a neurostimulator usage (e.g. see [0014]), said neurostimulator device having a set of prescribed treatment parameter values for said at least one therapy session (e.g. see [0018]); and, (b) at least one processor located external to the patient (e.g. see figure 1 elements 30-60, figure 3 element 552, [0028]-[0030]) in communication with said neurostimulator configured to monitor and record a set of patient usage data related to operations of said neurostimulator (e.g. see figure 2 steps 110-160, [0021]-[0027]) during said at least one therapy session, said at least one processor further configured to: (1) evaluate said set of patient usage data in relation to said set of prescribed treatment parameter values to determine at least one patient use measure (e.g. see [0014], [0021]-[0022], [0025]-[0027]); (2) calculate and transmit to a display module (e.g. see figure 1 element 50) a report which displays at least one selected patient usage measure of said at least one therapy session for each of a pre-selected calendar therapy session time intervals of a plurality of said therapy sessions and each of a pre-selected calendar time interval of a plurality of pre-selected calendar time intervals independent of a set of therapy session neurostimulator operational times (e.g. see [0014], [0021]-[0022], [0025]-[0027]. “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”), wherein information is displayed by the display module for each pre-selected calendar time interval which is determined to be compliant in accordance with said treatment regimen according to at least one compliance criterion (e.g. see [0014], [0021]-[0022], [0025]-[0027]).
Howser discloses the invention but is silent as to determining patient compliance with said prescribed treatment values and compliance in accordance with said treatment regimen according to at least one compliance criterion. Southwell teaches that it is known to use such a modification as set forth on page 47 lines 1-7 (Note: “treatment levels used” will read on “compliance criterion”. Also note Southwell displays compliance data in calendar form) to provide the clinician with data to assess compliance in relation to the schedule (e.g. see page 47 lines 1-7). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use such a modification as taught by Southwell in the system/method of Howser, since said modification would provide the predictable results of allowing the clinician with data to assess compliance in relation to the schedule.
Regarding claim 2, Howser discloses said pre-selected calendar therapy time interval is a day (e.g. see [0014] and [0022], “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”).
Regarding claim 3, Howser discloses the invention but is silent as to said display module display is formatted as a calendar display. Southwell teaches that it is known to use such a modification as set forth on page 47 lines 1-7 to provide the clinician with data to assess compliance in relation to the schedule (e.g. see page 47 lines 1-7). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a calendar display as taught by Southwell in the system/method of Howser, since said modification would provide the predictable results of allowing the clinician with data to assess compliance in relation to the schedule.
Regarding claim 8, Howser discloses said at least one processor is configured to display said report of said at least one patient usage measure for each day of a plurality of days (e.g. see [0014] and [0022], “date used”), wherein said at least one processor is located in a computer of a medical clinic that is connected to the internet and configured for remote monitoring of said patient usage measure (e.g. see figure 1 elements 40, 50, 60).
Regarding claim 9, Howser discloses the invention but is silent as to at least one processor is contained within a smartphone and configured as a user/physician programmer which is in communication with, and controls said neurostimulator, and further displays compliance information to the patient in accordance with said treatment regimen and according to one compliance criterion. Southwell teaches that it is known to use such a modification as set forth on page 13 lines 24-31, page 14 lines 4-7 to allow different possible stimulation control configurations. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a smartphone controller as taught by Southwell in the system of Howser, since said modification would provide the predictable results of allowing different possible stimulation control configurations and monitoring of treatment using a known communication device with telecommunication and internet capabilities.
Regarding claim 10, Howser discloses said report includes at least one patient usage measure includes a per day usage by said patient for each day (e.g. see [0014] and [0022], “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”).
Regarding claim 12, Howser discloses said display module displays a therapy summary table having at least one weekly summary statistic (e.g. see [0014], [0022], figure 1 element 50).
Regarding claim 13, Howser discloses said display module displays a graphical display of patient compliance and non-compliance with said treatment regimen (e.g. see [0014], [0022], figure 1 element 50).
Regarding claim 15, Howser discloses said neurostimulator is positioned to stimulate a patient's saphenous nerve with a stimulation protocol configured to provide treatment of a pelvic floor disorder (e.g. see figure 1 element 20. Note: This is a functional use limitation of a system claim. The prior art is capable of and/or configured to meet this limitation).
Regarding claim 16, Howser discloses said neurostimulation device is positioned and configured to electrically or magnetically stimulate said patient's saphenous nerve with said set of prescribed treatment parameter values defining a stimulation signal or set of stimulation signals having a stimulus characteristic for treating a pelvic floor disorder through stimulation of the patient's saphenous nerve (e.g. see figure 1 element 20. Note: This is a functional use limitation of a system claim. The prior art is capable of and/or configured to meet this limitation).
Regarding claim 17, Howser discloses said pelvic floor disorder is an overactive bladder (e.g. see figure 1 element 20. Note: This is a functional use limitation of a system claim. The prior art is capable of and/or configured to meet this limitation).
Regarding claim 20, Howser discloses said display module is adapted to display a schedule of scheduled therapy events to the patient which includes stimulation treatment times stored in a digital storage which communicates with said at least one processor (e.g. see [0014], [0022], figure 1 element 50).
Regarding claim 21, Howser discloses said display module is adapted to display a schedule of scheduled therapy events which includes a schedule of treatment times contingently modified based upon assessment of a patient's input data, based upon rules or lookup tables of the compliance module operating upon said patient input, said patient input being related to symptoms (e.g. see [0014], [0022], figure 1 element 50).
Claim(s) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howser and Southwell as applied to claim 1 above, in view of Hartley et al. (Pub No.: US 2005/0061319 A1); hereinafter referred to as “Hartley”.
Regarding claim 4, Howser discloses the invention measuring compliance for a minimum time interval (e.g. see [0014] and [0022], “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”), but is silent as to said patient is determined to be compliant for providing a required neurostimulation treatment operation for said preselected therapy session time interval only if said patient provides a minimum therapy session time interval of stimulation in said preselected time interval, as assessed by the at least one treatment compliance criterion. Hartley teaches that it is known to use such a modification as set forth in [0058], figure 1D (“the duration of the usage”) to allow the physician or patient to adjust the therapy to increase compliance (e.g. see [0058]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use such a modification as taught by Hartley in the system/method of Howser and Southwell, since said modification would provide the predictable results of allowing the physician or patient to adjust the therapy to increase compliance.
Regarding claim 5, Howser discloses said preselected therapy session time interval is within the range between 5-30 minutes (e.g. see [0018]).
Regarding claim 6, Howser discloses said patient is determined to be compliant only if a minimum amplitude of stimulation by said neurostimulator is applied for 30 minutes (e.g. see [0014], [0018]. “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”).
Regarding claim 7, Howser discloses the minimum amplitude of stimulation for said treatment therapy is selected by a medical doctor or medical caregiver (e.g. see [0014], [0018]. “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”).
Claim(s) 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howser and Southwell as applied to claim 1 above, and further in view of Cazares et al. (Pub. No.: US 2008/0162182 A1); hereinafter referred to as “Cazares”.
Regarding claim 11, Howser and Southwell disclose the invention but are silent as to a compliance module configured to provide an alert signal to said patient selected from the group of: an auditory signal, a visual signal or a tactile signal when said evaluation by said at least one processor determines that said patient is not in compliance with said treatment regimen. Cazares teaches that it is known to use such a modification as set forth in figures 7 and 8, [0101]-[0120] to provide more rapid notifications and thus response. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an alert as taught by Cazares in the system of Howser and Southwell, since said modification would provide the predictable results of more rapid notifications and thus response.
Regarding claim 14, Howser and Southwell disclose the invention but is silent as to said at least one stimulation device is an implanted neurostimulator which is activated by and controlled from an external controller during a plurality of therapy sessions in accordance with said prescribed regimen. Cazares teaches that it is known to use such a modification as set forth in figure 1, [0068]-[0070] to provide a device capable of treating a wider range of conditions. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an IMD as taught by Cazares in the system of Howser and Southwell, since said modification would provide the predictable results of a device capable of treating a wider range of conditions.
Claim(s) 18-19 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howser and Southwell as applied to claim 1 above, and further in view of Patangay et al. (Pub. No.: US 2008/0319272 A1); hereinafter referred to as “Patangay”.
Regarding claims 18-19, Howser and Southwell disclose the claimed invention except for said display module report which is displayed for at least one pre-selected time interval includes also reporting compliance of the user for completing at least one unscheduled event different from a set of events in said prescribed regimen and said at least one unscheduled event includes responding to a set of survey items selected from the group of: a quality-of-life survey, a survey of symptom data, an electronic bladder diary, a survey of concerning medical conditions, and combinations thereof. Patangay teaches that it is known to use such a modification as set forth in [0050], figure 9 to provide a more comprehensive emotional and physical assessment of the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to survey the patient as taught by Patangay in the system of Howser and Southwell, since said modification would provide the predictable results of a more comprehensive emotional and physical assessment of the patient.
Regarding claims 22-23, Howser and Southwell disclose the claimed invention except for said patient's input data includes an assessment by said patient indicating improvement of said patient's symptoms, worsening of said patient's symptoms, or no change in said patient's symptoms and the set of patient usage data is further related to operations including responding to a set of survey items selected from the group of: a quality-of-life survey, a survey of symptom data, an electronic bladder diary, a survey of concerning medical conditions, and combinations thereof. Patangay teaches that it is known to use such a modification as set forth in [0050], figure 9 to provide a more comprehensive emotional and physical assessment of the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to survey the patient as taught by Patangay in the system of Howser and Southwell, since said modification would provide the predictable results of a more comprehensive emotional and physical assessment of the patient.
Claim Rejections - 35 USC § 103 (alternate rejection)
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 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) 1-2, 4-8, 10, 12-13, 15-17, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howser et al. (Pub. No.: US 2004/0204962 A1); hereinafter referred to as “Howser”, in view of Hartley et al. (Pub No.: US 2005/0061319 A1); hereinafter referred to as “Hartley”.
Regarding claim 1, Howser discloses a neurostimulation system (e.g. see figure 1 element 10) for operating upon and displaying usage data corresponding to providing therapy operations with a neurostimulation therapy system comprising: (a) a neurostimulation device (e.g. see figure 1 element 20) including a neurostimulator adapted to apply an electrical or magnetic signal to a patient's body (e.g. see [0016]-[0018]) during at least one therapy session in accordance with a prescribed regimen (e.g. see [0018]), said operation of said neurostimulator during said at least one therapy session defining a neurostimulator usage (e.g. see [0014]), said neurostimulator device having a set of prescribed treatment parameter values for said at least one therapy session (e.g. see [0018]); and, (b) at least one processor located external to the patient (e.g. see figure 1 elements 30-60, figure 3 element 552, [0028]-[0030]) in communication with said neurostimulator configured to monitor and record a set of patient usage data related to operations of said neurostimulator (e.g. see figure 2 steps 110-160, [0021]-[0027]) during said at least one therapy session, said at least one processor further configured to: (1) evaluate said set of patient usage data in relation to said set of prescribed treatment parameter values to determine at least one patient use measure (e.g. see [0014], [0021]-[0022], [0025]-[0027]); (2) calculate and transmit to a display module (e.g. see figure 1 element 50) a report which displays at least one selected patient usage measure of said at least one therapy session for each of a pre-selected calendar therapy session time intervals of a plurality of said therapy sessions and each of a pre-selected calendar time interval of a plurality of pre-selected calendar time intervals independent of a set of therapy session neurostimulator operational times (e.g. see [0014], [0021]-[0022], [0025]-[0027]. “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”), wherein information is displayed by the display module for each pre-selected calendar time interval which is determined to be compliant in accordance with said treatment regimen according to at least one compliance criterion (e.g. see [0014], [0021]-[0022], [0025]-[0027]).
Howser discloses the invention but is silent as to determining patient compliance with said prescribed treatment values and compliance in accordance with said treatment regimen according to at least one compliance criterion. Hartley teaches that it is known to use such a modification as set forth in [0058], figure 1D to allow the physician or patient to adjust the therapy to increase compliance (e.g. see [0058]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use such a modification as taught by Hartley in the system/method of Howser, since said modification would provide the predictable results of allowing the physician or patient to adjust the therapy to increase compliance.
Regarding claim 2, Howser discloses said pre-selected calendar therapy time interval is a day (e.g. see [0014] and [0022], “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”).
Regarding claim 4, Howser discloses the invention measuring compliance for a minimum time interval (e.g. see [0014] and [0022], “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”), but is silent as to said patient is determined to be compliant for providing a required neurostimulation treatment operation for said preselected therapy session time interval only if said patient provides a minimum therapy session time interval of stimulation in said preselected time interval, as assessed by the at least one treatment compliance criterion. Hartley teaches that it is known to use such a modification as set forth in [0058], figure 1D (“the duration of the usage”) to allow the physician or patient to adjust the therapy to increase compliance (e.g. see [0058]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use such a modification as taught by Hartley in the system/method of Howser, since said modification would provide the predictable results of allowing the physician or patient to adjust the therapy to increase compliance.
Regarding claim 5, Howser discloses said preselected therapy session time interval is within the range between 5-30 minutes (e.g. see [0018]).
Regarding claim 6, Howser discloses said patient is determined to be compliant only if a minimum amplitude of stimulation by said neurostimulator is applied for 30 minutes (e.g. see [0014], [0018]. “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”).
Regarding claim 7, Howser discloses the minimum amplitude of stimulation for said treatment therapy is selected by a medical doctor or medical caregiver (e.g. see [0014], [0018]. “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”).
Regarding claim 8, Howser discloses said at least one processor is configured to display said report of said at least one patient usage measure for each day of a plurality of days (e.g. see [0014] and [0022], “date used”), wherein said at least one processor is located in a computer of a medical clinic that is connected to the internet and configured for remote monitoring of said patient usage measure (e.g. see figure 1 elements 40, 50, 60).
Regarding claim 10, Howser discloses said report includes at least one patient usage measure includes a per day usage by said patient for each day (e.g. see [0014] and [0022], “Examples of compliancy data may include patient use data such as, but not by way of limitation, amplitude settings, time used, date used, total treatment time, and/or mode of treatment”).
Regarding claim 12, Howser discloses said display module displays a therapy summary table having at least one weekly summary statistic (e.g. see [0014], [0022], figure 1 element 50).
Regarding claim 13, Howser discloses said display module displays a graphical display of patient compliance and non-compliance with said treatment regimen (e.g. see [0014], [0022], figure 1 element 50).
Regarding claim 15, Howser discloses said neurostimulator is positioned to stimulate a patient's saphenous nerve with a stimulation protocol configured to provide treatment of a pelvic floor disorder (e.g. see figure 1 element 20. Note: This is a functional use limitation of a system claim. The prior art is capable of and/or configured to meet this limitation).
Regarding claim 16, Howser discloses said neurostimulation device is positioned and configured to electrically or magnetically stimulate said patient's saphenous nerve with said set of prescribed treatment parameter values defining a stimulation signal or set of stimulation signals having a stimulus characteristic for treating a pelvic floor disorder through stimulation of the patient's saphenous nerve (e.g. see figure 1 element 20. Note: This is a functional use limitation of a system claim. The prior art is capable of and/or configured to meet this limitation).
Regarding claim 17, Howser discloses said pelvic floor disorder is an overactive bladder (e.g. see figure 1 element 20. Note: This is a functional use limitation of a system claim. The prior art is capable of and/or configured to meet this limitation).
Regarding claim 20, Howser discloses said display module is adapted to display a schedule of scheduled therapy events to the patient which includes stimulation treatment times stored in a digital storage which communicates with said at least one processor (e.g. see [0014], [0022], figure 1 element 50).
Regarding claim 21, Howser discloses said display module is adapted to display a schedule of scheduled therapy events which includes a schedule of treatment times contingently modified based upon assessment of a patient's input data, based upon rules or lookup tables of the compliance module operating upon said patient input, said patient input being related to symptoms (e.g. see [0014], [0022], figure 1 element 50).
Claim(s) 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howser and Hartley in view of Gustavson et al. (Pub. No.: US 2015/0331996 A1); hereinafter referred to as “Gustavson”.
Regarding claim 3, Howser and Hartley disclose the invention but is silent as to said display module display is formatted as a calendar display. Gustavson teaches that it is known to use such a modification as set forth in [0058], figures 6-9 to provide a more intuitive compliance interface. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a calendar view as taught by Gustavson in the system of Howser and Hartley, since said modification would provide the predictable results of a more intuitive compliance interface.
Regarding claim 9, Howser and Hartley disclose the invention but is silent as to at least one processor is contained within a smartphone and configured as a user/physician programmer which is in communication with, and controls said neurostimulator, and further displays compliance information to the patient in accordance with said treatment regimen and according to one compliance criterion. Gustavson teaches that it is known to use such a modification as set forth in [0052], figure 6 to provide a more convenient compliance interface. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a smartphone controller as taught by Gustavson in the system of Howser and Hartley, since said modification would provide the predictable results of a more convenient compliance interface.
Claim(s) 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howser and Hartley in view of Cazares et al. (Pub. No.: US 2008/0162182 A1); hereinafter referred to as “Cazares”.
Regarding claim 11, Howser and Hartley disclose the invention but is silent as to a compliance module configured to provide an alert signal to said patient selected from the group of: an auditory signal, a visual signal or a tactile signal when said evaluation by said at least one processor determines that said patient is not in compliance with said treatment regimen. Cazares teaches that it is known to use such a modification as set forth in figures 7 and 8, [0101]-[0120] to provide more rapid notifications and thus response. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an alert as taught by Cazares in the system of Howser and Hartley, since said modification would provide the predictable results of more rapid notifications and thus response.
Regarding claim 14, Howser and Hartley disclose the invention but is silent as to said at least one stimulation device is an implanted neurostimulator which is activated by and controlled from an external controller during a plurality of therapy sessions in accordance with said prescribed regimen. Cazares teaches that it is known to use such a modification as set forth in figure 1, [0068]-[0070] to provide a device capable of treating a wider range of conditions. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an IMD as taught by Cazares in the system of Howser and Hartley, since said modification would provide the predictable results of a device capable of treating a wider range of conditions.
Claim(s) 18-19 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howser and Hartley in view of Patangay et al. (Pub. No.: US 2008/0319272 A1); hereinafter referred to as “Patangay”.
Regarding claims 18-19, Howser and Hartley disclose the claimed invention except for said display module report which is displayed for at least one pre-selected time interval includes also reporting compliance of the user for completing at least one unscheduled event different from a set of events in said prescribed regimen and said at least one unscheduled event includes responding to a set of survey items selected from the group of: a quality-of-life survey, a survey of symptom data, an electronic bladder diary, a survey of concerning medical conditions, and combinations thereof. Patangay teaches that it is known to use such a modification as set forth in [0050], figure 9 to provide a more comprehensive emotional and physical assessment of the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to survey the patient as taught by Patangay in the system of Howser and Hartley, since said modification would provide the predictable results of a more comprehensive emotional and physical assessment of the patient.
Regarding claims 22-23, Howser and Hartley disclose the claimed invention except for said patient's input data includes an assessment by said patient indicating improvement of said patient's symptoms, worsening of said patient's symptoms, or no change in said patient's symptoms and the set of patient usage data is further related to operations including responding to a set of survey items selected from the group of: a quality-of-life survey, a survey of symptom data, an electronic bladder diary, a survey of concerning medical conditions, and combinations thereof. Patangay teaches that it is known to use such a modification as set forth in [0050], figure 9 to provide a more comprehensive emotional and physical assessment of the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to survey the patient as taught by Patangay in the system of Howser and Hartley, since said modification would provide the predictable results of a more comprehensive emotional and physical assessment of the patient.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached on 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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