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 arguments filed 9/2/2025 have been considered but are moot in view of the new ground(s) of rejection as necessitated by the applicant’s claim amendments. In particular, the examiner is utilizing the Hartley reference to address the new claim limitations in claims 1 and 4.
Continuity Data
The compliance limitations are supported through provisional application 62/375,898, thus the application is given priority to 8/16/2016. The CIP’s that split off 15/678,824 do not appear to contain the compliance limitations.
Claim Rejections - 35 USC § 103
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 (e.g. see figure 1 elements 30-60) in communication with said neurostimulator configured to monitor and record a set of patient usage data related to operations of said neurostimulator during said at least one therapy session in accordance with said prescribed regimen (e.g. see figure 2, [0021]-[0027]), said at least one processor further configured to: (1) evaluate said patient set of patient usage data in relation to said set of prescribed treatment parameter values to determine 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 for each of a pre-selected time interval of a plurality of pre-selected time intervals (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 for each pre-selected time interval which is determined to be compliant (e.g. see [0014], [0021]-[0022], [0025]-[0027]), information is displayed by the display module (e.g. see figure 1 element 50).
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 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 preselected time interval only if said patient provides a minimum 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 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
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Kish can be reached on 571-272-5554. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP C EDWARDS/Examiner, Art Unit 3792
/JAMES M KISH/Supervisory Patent Examiner, Art Unit 3792