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 amendments filed 6/30/2026 merit new grounds for rejection in view of Gozani 996. In particular, the examiner has changed the motivation to combine from Gozani 996. The rejection now states: “Gozani discloses receiving impedance data from an impedance sensor associated with the patient (e.g. see [0010]) but silent as to determining a usage level based on the impedance data, the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode. Gozani 996 teaches it is known to use such a modification as set forth in [0123]-[0126] (Note: In [0124], the “stimulation current intensity” will read on “usage level” as current is a form of “usage” and intensity is a form of “level”. Thus, the amount of current applied is a “usage level”. The applicant has used the language “the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode”. The phrase “corresponding to” may be interpreted broadly. The time stamps in Gozani 996 will “correspond to” the stimulation current intensity as the time stamps are done at the time of the recorded current intensity data) to modify the stimulation currently being applied based on historical usage and impedance data (e.g. see [0125]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to determine a usage level based on the impedance data, the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode as taught by Gozani 996 in the system/method of Gozani, since said modification would provide the predictable results of modifying the stimulation currently being applied based on historical usage and impedance data”.
Applicant's arguments filed 6/30/2026 have been fully considered but they are not persuasive. As noted above, claims 1-9, 11-16, 21-25, and 28-30 are rejected under new grounds for rejection. Applicant’s remarks on p. 8-9 discussing Gozani and Shahrani alone are not considered persuasive because the claims are rejected further in view of the Gozani 996.
Applicant argues on page 10 “First, Gozani 996 uses impedance data to predict the physical degradation and remaining useful life of a consumable electrode assembly - i.e., when the electrode's hydrogel adhesive has deteriorated to the point that the electrode pad must be replaced. This is a consumable- life/maintenance metric focused on the physical condition of a hardware component. Gozani 996 does not teach or suggest determining a usage level that "correspond[s] to a period of time during which the electrical impulse is provided to the electrode" as required by amended Claims 1 and 30. Notably, Claims 1 and 30 recite specific programmatic steps - a computer program configured to cause a processor to perform a sequence of operations, and a method comprising specific steps, respectively - none of which find any parallel in Gozani 996's electrode degradation monitoring”.
The examiner is not persuaded. In [0124], the “stimulation current intensity” will read on “usage level” as current is a form of “usage” and intensity is a form of “level”. Thus, the amount of current applied is a “usage level”. The applicant has used the language “the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode”. The phrase “corresponding to” may be interpreted broadly. The time stamps in Gozani 996 will “correspond to” the stimulation current intensity as the time stamps are done at the time of the recorded current intensity data. Regarding the arguments towards “consumable-life/maintenance metric” and “degradation monitoring”, the examiner has changed the motivation to combine to the subject matter in [0125] focused on modifying the stimulation currently being applied based on historical usage and impedance data. Delivering more appropriate stimulation is a universally desired improvement in any electrical stimulation device, including for the primary reference, Gozani 709.
Applicant argues on page 10 “Second, Gozani 996 itself distinguishes between measuring "on-skin time" (how long the device has been worn/used) and measuring electrode degradation (whether the electrode needs replacement). Indeed, one of the references cited within Gozani 996 is US 2015/0306387 to Neurometrix, which is entitled "Measuring the 'on-skin' time of a transcutaneous electrical nerve stimulator (TENS) device in order to minimize skin irritation due to excessive uninterrupted wearing of the same". This reference measures on-skin time for the purpose of managing skin irritation - yet another distinct purpose from the present claims. The fact that the Gozani 996 family of references itself treats electrode-life prediction and on-skin time measurement as different concepts confirms that determining a usage level corresponding to a period of active stimulation delivery - i.e., a treatment compliance metric - is a distinct concept not taught by any of the cited references”.
The examiner is not persuaded. Regarding the arguments towards “on skin time”, the examiner has changed the motivation to combine to the subject matter in [0125] focused on modifying the stimulation currently being applied based on historical usage and impedance data. Thus, this argument is not persuasive.
Applicant argues on pages 11-12 “1. The Cited References Teach Away from the Claimed Use of Impedance Data”. Specifically, the applicant argues Gozani 996 is directed towards assessing the condition of the electrode, which is purely an assessment of the hardware condition at the moment.
The examiner is not persuaded. The property attributes measured in [0124] of Gozani 996 are used to deliver better stimulation in [0125]. The better or more appropriate stimulation delivered in [0125] is more than just a hardware assessment, which renders this argument unpersuasive.
Applicant argues on page 12 “2. Repurposing Impedance Data as a Temporal Metric Requires a Conceptual Leap Not Supported by the Prior Art”. Applicant specifically argues on page 12 that the examiner uses hindsight reasoning.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant also argues on page 12 “None of the cited references teaches or suggests any link between impedance measurements and the quantification of stimulation delivery time”.
The applicant is now arguing limitations not claimed as “quantification of stimulation delivery time” is very different than the actual claim language. In [0124], the examiner is interpreting “stimulation current intensity” as the “usage level”, the “time stamps” as “a period of time during which the electrical impulse is provided to the electrode”. The applicant has used the language “the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode”. The phrase “corresponding to” may be interpreted broadly. The time stamps in Gozani 996 will “correspond to” the stimulation current intensity as the time stamps are done at the time of the recorded current intensity data. Applicant appears to be interpreting “the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode” as a “quantification of stimulation delivery time”. Under the doctrine of BRI, no specific quantification is claimed as the usage level is not claimed as a time quantity, and must merely correspond to time. As noted above, this is met by Gozani 996.
Applicant argues on page 13 “3. No Articulated Rationale Supports the Specific Modification Required”. Applicant specifically argues “The Examiner's stated motivation for combining Gozani with Gozani 996 - "to predict the useful life of the smart electrode assembly before replacement is needed" – actually confirms that the prior art's use of impedance data is directed toward consumable-life management, not toward treatment compliance monitoring. The Examiner has not articulated, and Applicant respectfully submits cannot articulate, a reason why a skilled artisan would look at Gozani's electrode-peeling safety cutoff or Gozani 996's electrode-degradation prediction and conclude that impedance data should instead be used to determine how long stimulation has been actively delivered to the patient as a compliance metric.”
The examiner is not persuaded. The Gozani 996 reference is not just directed towards “electrode-peeling safety cutoff” or “electrode-degradation prediction”. The property attributes measured in [0124] of Gozani 996 are used to deliver better stimulation in [0125]. The better or more appropriate stimulation delivered in [0125] is now the current motivation to combine.
Applicant argues on pages 14-15 that Gozani 386, Karim, and Sit do not teach the newly added language in the independent claim. The examiner agrees. Gozani 996 is cited for the new 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) 1-9, 11-16, 21-25, and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani et al. (Pub. No.: US 2014/0309709 A1); hereinafter referred to as “Gozani”, in view of Gozani et al. (Pub. No.: US 2018/0177996 A1); hereinafter referred to as “Gozani 996”, and Shahriari et al. (Pub. No.: US 2019/0167988 A1).
Regarding claims 1, 21, and 30, Gozani discloses a computer program (e.g. see [0061]) configured to cause a processor (e.g. see figure 2B element 515, [0061]) to: provide, using an electrode (e.g. see figure 2B elements 420, 432, [0056]), an electrical impulse to a skin of the patient at a target site; receive impedance data from an impedance sensor associated with the patient (e.g. see [0010]); receive motion data from a motion sensor associated with the patient (e.g. see figure 2B element 152, [0053], [0058]); determine an activity level (e.g. see figure 6 elements 301-304, [0097]) for a sample of the motion data over a time frame (e.g. see figure 6 elements 305-309, [0097]), wherein the activity level is chosen from a set of activity intensity ranges (e.g. see figure 6 elements 301-304, [0097]); and generate a data digest comprising a plurality of activity levels over a plurality of time frames (e.g. see figure 9 elements 335-337, [0100], “The activity level count MT for an epoch is the average of the instantaneous acceleration data within that epoch”), wherein at least one time frame of the plurality of time frames is associated with the providing of the electrical impulse (e.g. see figure 10, [0102]-[0107]).
Gozani discloses receiving impedance data from an impedance sensor associated with the patient (e.g. see [0010]) but silent as to determining a usage level based on the impedance data, the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode. Gozani 996 teaches it is known to use such a modification as set forth in [0123]-[0126] (Note: . In [0124], the “stimulation current intensity” will read on “usage level” as current is a form of “usage” and intensity is a form of “level”. Thus, the amount of current applied is a “usage level”. The applicant has used the language “the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode”. The phrase “corresponding to” may be interpreted broadly. The time stamps in Gozani 996 will “correspond to” the stimulation current intensity as the time stamps are done at the time of the recorded current intensity data (e.g. see [0125]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to determine a usage level based on the impedance data, the usage level corresponding to a period of time during which the electrical impulse is provided to the electrode as taught by Gozani 996 in the system/method of Gozani, since said modification would provide the predictable results of modifying the stimulation currently being applied based on historical usage and impedance data.
Gozani and Gozani 996 disclose the claimed invention but are silent as to a non-transitory computer readable storage medium (CRM) for treating a patient, the non-transitory computer readable storage medium. Shahriari teaches it is known to use such a modification as set forth in figure 11 elements 704, 706, 707, [0095], figure 12 to provide means to store and run the treatment programs. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the CRM as taught by Shahriari in the system of Gozani and Gozani 996, since said modification would provide the predictable results of means to store and run the treatment programs.
Regarding claims 2 and 22, Gozani discloses the data digest comprises a frequency of the activity level over the plurality of time frames (e.g. see figure 9 element 304, [0100]. Note that the frequency of signal 304 increases with activity level increases).
Regarding claims 3 and 23, Gozani and Gozani 996 disclose the claimed invention but are silent as to the computer program is configured to cause the processor to transmit the data digest to a remote device. Shahriari teaches it is known to use such a modification as set forth in figure 11 element 725 and figure 12 elements 800/900 to process a large quantity of data that must be manipulated, transformed, refined, reduced, or changed from one state to another to be able to efficiently resolve into meaningful segments of data that the user or clinician can utilize and make medical based judgments upon (e.g. see [0105]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to transmit the data digest to a remote device as taught by Shahriari in the system/method of Gozani and Gozani 996, since said modification would provide the predictable results of processing a large quantity of data that must be manipulated, transformed, refined, reduced, or changed from one state to another to be able to efficiently resolve into meaningful segments of data that the user or clinician can utilize and make medical based judgments upon.
Regarding claims 4 and 24, Gozani discloses the data digest is used to generate a report comprising a histogram for the set of activity intensity ranges (e.g. see figure 9 elements 335-337, [0100]).
Regarding claim 5, Gozani and Gozani 996 disclose the claimed invention but are silent as to the report is displayed on a remote device. Shahriari teaches it is known to use such a modification as set forth in [0101], [0105] to efficiently resolve into meaningful segments of data that the user or clinician can utilize and make medical based judgments upon (e.g. see [0105]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to display the data digest on a remote device as taught by Shahriari in the system/method of Gozani and Gozani 996, since said modification would provide the predictable results of efficiently resolving into meaningful segments of data that the user or clinician can utilize and make medical based judgments upon.
Regarding claims 6 and 25, Gozani discloses the set of activity intensity ranges comprises at least three activity intensity ranges (e.g. see figure 9 elements 335-337, [0100]).
Regarding claims 7 and 29, Gozani discloses the activity level is determined by calculating an activity parameter from the sample of the motion data over the time frame and parsing the activity parameter into an activity intensity range from the set of the activity intensity ranges (e.g. see figure 9 elements 335-337, [0100]).
Regarding claim 8, Gozani discloses the activity parameter comprises an average vector (e.g. see [0075]) magnitude of the sample of the motion data over the time frame (e.g. see figure 9 elements 335-337, [0100], “The activity level count MT for an epoch is the average of the instantaneous acceleration data within that epoch”).
Regarding claim 9, Gozani discloses determining the activity level is configured to reduce a data size of the data digest as compared to a data size of the motion data (e.g. see figure 9 element 334, 304, figure 6 elements 301-304, [0100]. Note: The data size in figure 9 element 334 is much smaller than that of figure 6).
Regarding claim 11, Gozani discloses the motion sensor is attached to the patient (e.g. see [0052]-[0053], figure 1).
Regarding claim 12, Gozani discloses the impedance sensor is coupled to the electrode (e.g. see [0010]).
Regarding claim 13, Gozani discloses the impedance data is based on the electrical impulse provided to the skin of the patient (e.g. see [0010]).
Regarding claim 14, Gozani discloses the computer program is configured to cause the processor to modify a parameter of the electrical impulse based on the impedance data (e.g. see [0010]. Note: Termination of stimulation will read on modifying a parameter).
Regarding claim 15, Gozani discloses the parameter of the electrical impulse comprises an amplitude, a frequency, a duty cycle, a pulse width, or a pulse shape, or a combination thereof (e.g. see [0010]. Note: Termination of stimulation will read on modifying these parameters).
Regarding claim 16, Gozani and Shahriari discloses the invention but are silent as to the data digest further comprises a usage level based on a plurality of the impedance data over the plurality of time frames. Gozani 996 teaches it is known to use such a modification as set forth in [0123]-[0126] (Note: In [0124], the “stimulation current intensity” will read on “usage level”. The “time stamps” will read on “time frames”) to modify the stimulation currently being applied based on historical usage and impedance data (e.g. see [0124]-[0125]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have the data digest further comprising a usage level based on a plurality of the impedance data over the plurality of time frames as taught by Gozani 996 in the system/method of Gozani and Shahriari, since said modification would provide the predictable results of modifying the stimulation currently being applied based on historical usage and impedance data.
Regarding claim 28, Gozani discloses a housing (e.g. see [0053], figure 2 elements 101, 102, 103), wherein the electrode, motion sensor and impedance sensor are housing within, or on, the housing.
Claim(s) 10 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of Gozani 996 and Shahriari as applied to claim 1 above, and further in view of Gozani et al. (Pub. No.: US 2019/0022386 A1); hereinafter referred to as “Gozani 386”.
Regarding claims 10 and 26, Gozani, Gozani 996, and Shahriari disclose the invention but are silent as to the motion data comprises about 5 outputs to about 100 outputs per second. Gozani 386 teaches it is known to use such a modification as set forth in [0155] to provide acceleration data detection of acceleration “pulse” events (e.g. see [0155]) (Note: The applicant does not provide criticality for the range of 5-100 outputs per second. [00104] of the applicant’s filed specification only states this range may be used but does provide criticality to this specific claimed range). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use motion data detection frequencies as taught by Gozani 386 in the system/method of Gozani, Gozani 996, and Shahriari, since said modification would provide the predictable results of acceleration data detection of acceleration “pulse” events.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of Gozani 996 and Shahriari as applied to claim 1 above, and further in view of Karim (Pub. No.: US 2012/0316482 A1).
Regarding claims 17-19, Gozani, Gozani 996, and Shahriari disclose the invention but are silent as to the electrode is placed on the skin over or near a spine of the patient, the electrical impulse is configured to enhance bone healing in the patient, and the electrical impulse is applied non-invasively. Karim teaches it is known to use such a modification as set forth in [0030]-[0031] to provide healing or re-calcification to greater degree with the present device (e.g. see [0027]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use non-invasive bone healing stimulation at the spine as taught by Karim in the system/method of Gozani, Gozani 996, and Shahriari, since said modification would provide the predictable results of healing or re-calcification to greater degree with the present device.
Claim(s) 20 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gozani in view of Gozani 996 and Shahriari as applied to claim 1 above, and further in view of Sit et al. (Pub. No.: US 2020/0139138 A1); hereinafter referred to as “Sit”.
Regarding claims 20 and 27, Gozani, Gozani 996, and Shahriari disclose the claimed invention except for the electrical impulse has an amplitude of about 3 mA to about 10 mA. Sit teaches it is known to use such a modification as set forth in [0137], [0211], and [0254] to provide enhanced treatment of pain and other enhanced benefits (e.g. see [0006]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use an amplitude of about 3 mA to about 10 mA as taught by Sit in the system/method of Gozani, Gozani 996, and Shahriari, since said modification would provide the predictable results of enhanced treatment of pain and other enhanced benefits.
Conclusion
THIS ACTION IS MADE FINAL. 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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