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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07JUL2025, which incorporates the amendments made in the After Final Response filed 23MAY2025, has been entered.
Status of Claims
The amendments and remarks filed on 07JUL2025 have been entered and considered.
Claims 40-58 are currently pending.
No claims have been amended.
Claims 1-15, 20-32, & 38-39 have been canceled.
Claims 40-58 have been added
Claims 40, 46, 48-50, 55, & 58 contain new matter.
Claims 40-58 are under examination.
Response to Arguments
Applicant's amendments filed 07JUL2025 regarding the 112(f) interpretations have been fully considered and obviate the interpretations. Therefore, they have been withdrawn.
Applicant's arguments filed 07JUL2025 with respect to claim(s) 40 & 50 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 41, 45, 47-48, 54, & 56-57 are objected to because of the following informalities:
Regarding claim 41:
The claim recites “walked by the use and an”. This appears to be missing punctuation, and should instead read “walked by the user, and an” to be correct.
The claim recites “taken by the use” in Line 2. This appears to contain a spelling error, and should instead read “taken by the user” to be correct.
Regarding claims 45 & 54:
The claim recites “pulse width and a pulse frequency” in Line 2. This appears to be missing punctuation, and should instead read “pulse width, and a pulse frequency” to be correct.
Regarding Claims 47 & 56:
The claim recites “having a first end and a second” in Line2. This appears to be missing punctuation, and should instead read “having a first end, and a second” to be correct.
Regarding claims 48 & 57:
The claims recite “L4, L5, S2 and S2 sensory dermatomes” in line 2. This appears to be a typographical error and should instead read: “L4, L5, S2 and S3 sensory dermatomes” to not include repeated “S2”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 40-58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims contain new matter.
Regarding claims 40 & 50:
The claimed second as claimed in claims 46 & 55. There is no indication of a sensor which detect gait variability (as seen in claim 40) or one that detects stride duration (ass seen in in claim 50) in the specification. A sensor gathers data that is then used to assess gait variability or stride duration. The specification does not provide information regarding a sensor which can detect the variability or duration, only items such as an accelerometer & gyroscope which are used to gather information regarding patient activity. The specification does not provide a disclosure of a sensor which may also analyze this raw data to obtain gait variability or stride duration as claimed in claims 40 & 50 respectively. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
Claims 41-49 are additionally rejected for depending upon rejected claim 40.
Claims 51-58 are additionally rejected for depending upon rejected claim 50.
Regarding claim 46 & 55:
The claimed treatment regimen as claimed in claims 46 & 55. There is no indication of a change to a regime of treatment in the specification. The discussions around adjustments made to electrical stimulation in the specification do not indicate a treatment regimen. In addition to this, treatment regime cannot be found in the specification to clarify what treatment regimen means. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
Regarding Claims 48 & 57:
The claimed L4, L5, S2 and S2 sensory dermatomes as claimed in claims 48 & 57. There is nothing indicating a specified type of dermatomes. In addition, none of the words L4; L5; S2; or dermatome can be found in the specification alone or in combination with the other words. Further, the meaning of each dermatome type (i.e. buttocks area, knee area, etc.) are not mentioned either in the specification. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
Claim 49 is rejected under 35 U.S.C. 112(a) for depending on Claim 48.
Regarding Claim 49 & 58:
The claimed diabetic peripheral neuropathy pain as claimed in claims 49 & 58 . There is nothing indicating a specified type of pain for the patient, or for the intended use of the invention within the specification. In addition, none of the words pain; diabetic; peripheral; or neuropathy can be found in the specification alone or in combination with the other words. The application has not shown possession of the claimed invention and therefore the claims are rejectable under 112a, written description for new matter.
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 40-58 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.
Regarding claims 40 & 50:
Claims 40 & 50 recites the limitation "the target location" in Line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 41-49 are additionally rejected for depending upon rejected claim 40.
Claims 51-58 are additionally rejected for depending upon rejected claim 50.
Regarding claims 49 & 58:
Claims 49 & 58 recites the limitation " the pain" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Duplicate claim warning
Applicant is advised that should claim 40 be found allowable, claim 50 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 40 & 50. After review, only the final sentences of claims 40 & 50 vary, with claim 40 stating gait variability and claim 50 stating stride duration. Since stride duration is an example of gait variability, these are substantially the same. The remaining parts of the limitations of claims 40 & 50 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 44 be found allowable, claim 53 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 44 & 53. After review, all parts of the limitations of claims 44 & 53 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 45 be found allowable, claim 54 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 45 & 54. After review, all parts of the limitations of claims 45 & 54 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 46 be found allowable, claim 55 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 46 & 55. After review, all parts of the limitations of claims 46 & 55 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 47 be found allowable, claim 56 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 47 & 56. After review, all parts of the limitations of claims 47 & 56 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 48 be found allowable, claim 57 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 48 & 57. After review, all parts of the limitations of claims 48 & 57 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
Applicant is advised that should claim 49 be found allowable, claim 58 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The claims stand as substantial duplicates because these claims are related to separate devices but are found to recite identical wording in claims 49 & 58. After review, all parts of the limitations of claims 49 & 58 are identical. The terms do not differ in scope as they are used to recite the same parts of the invention, nor do the terms have meanings that affect the limitations differently.
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.
Claims 40-42, 44-50, 53-54, & 57-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated Ganguly et al. (US Publication No. 20200061378).
Regarding claim 40, Ganguly discloses an apparatus for providing therapy to a user (Ganguly Abstract and Title) comprising a first sensor for detecting an isometric muscle activity of the user (Ganguly ¶0040 “A biomarker monitor may include one or more electrodes for detecting biopotentials, e.g., electromyogram (EMG), electroocculogram (EOG), electroencephalogram (EEG), etc. For example, any of these apparatuses may include one or more electrical sensors (e.g., EMG sensors, etc.) as part of a biomarker monitor. “ where a a EMG sensor is designed to detect muscle activities such as isometric movements.) and a second sensor for detecting a gait variability of the user (Ganguly ¶0036 “ny of these apparatuses, including the stimulator apparatus, may include one or more sensors, including but not limited to one or more motion sensors, position sensors (e.g., configured to determine the position of a portion of the subject's body), or the like.”; ); an electrode configured for contacting an outer skin surface of user (Ganguly ¶0023 “ The electrical stimulation may be applied transdermally (e.g., through the skin) or via one or more implanted electrodes or adhesive patch electrodes (on the skin surface).”); an energy source coupled to the electrode (Ganguly ¶0053 “n FIG. 6A a wrist-band device that stimulates the radial, ulnar and median nerves in the wrist includes nerve stimulating electrodes, sensors for hand/limb movement, battery and related electronic circuitry, and wireless sensor for connectivity to a display and/or EEG biomarker signal from the brain”), wherein the energy source is configured to generate at least one electrical impulse and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the user to a selected nerve in the user adjacent to, or near, the target location (Ganguly ¶0024 “Any of these methods may include placing a wearable transdermal stimulator onto one or more of the subject's arm and hand. For example, applying may comprise applying electrical stimulation from a wearable wrist band, a patch, or a smart glove.”); and a controller coupled to the wearable device (Ganguly ¶0008 “ a controller functionally coupled to the first input, wherein the controller is configured to apply an electrical stimulation to a peripheral nerve and to measure at least one of: a biomarker or a performance indicator from a task that activates the peripheral nerve to which the electrical stimulation was applied”) and configured to adjust a stimulation parameter of the electrical impulse based on either the isometric muscle activity (Ganguly ¶0034 “ adjust the stimulation parameters based on the measured biomarker, and transmit the adjusted stimulation parameters to the stimulator.”) or the gait variability of the user (Ganguly ¶0028 “Adjustment may be based on one or more indicators, as mentioned, including a biomarker (e.g., EEG signal) or performance metric. Any appropriate portion of the electrical stimulation parameters may be adjusted, including one or more of: intensity, current amplitude, frequency, duration, duty cycle, times/day, pulse duration, burst frequency, burst duration, or total treatment period. For example, adjusting the electrical stimulation may comprise increasing the intensity of stimulation.”; ¶0136 “Coordination of these movements may also be used to measure performance. For the lower limb, similar metrics are used. This may include gait parameters such as stride length, step length, base of stance, speed of movement and variability of steps”).
Regarding claim 41, Claim 40 is anticipated by Ganguly. Ganguly further discloses wherein the gait variability comprises one or more of a number of strides taken by the user, an amount of time walked by the user, and an average cadence of the user (Ganguly ¶0107 “The device may stimulate the lower limb (e.g. S1-S5; L1-5; branches of sciatic such as tibial and peroneal, femoral, obturator, saphenous, foot cutaneous nerves or plantar surface nerves with efficacy assessed using a bracelet at the ankle that can monitor step length, stride, gait speed or stance, motion capture of speed or use of camera to measure speed”).
Regarding claim 42, Claim 40 is anticipated by Ganguly. Ganguly further discloses wherein the second sensor detects a stride duration of the user (Ganguly ¶0036 “ny of these apparatuses, including the stimulator apparatus, may include one or more sensors, including but not limited to one or more motion sensors, position sensors (e.g., configured to determine the position of a portion of the subject's body), or the like.”).
Regarding claim 44, Claim 40 is anticipated by Ganguly. Ganguly further discloses wherein the first sensor comprises an electromyography sensor (Ganguly ¶0009 “For example, a biomarker monitor may include one or more electrodes for detecting biopotentials, e.g., electromyogram (EMG), electroocculogram (EOG), electroencephalogram (EEG), etc. For example, any of these apparatuses may include one or more electrical sensors (e.g., EMG sensors, etc.)”).
Regarding claim 45, Claim 40 is anticipated by Ganguly. Ganguly further discloses wherein the stimulation parameter comprises one of an amplitude, a pulse width and a pulse frequency of the electrical impulses (Ganguly ¶0016 “The stimulator may include one or more controllers. For example, a controller may be configured to adjust the electrical stimulation by adjusting one or more of: intensity, current amplitude, frequency, duration, duty cycle, times/day, pulse duration, burst frequency, burst duration, or total treatment period.”).
Regarding claim 46, Claim 40 is anticipated by Ganguly. Ganguly further discloses wherein the electrical impulses are generated and transmitted according to a treatment regimen, wherein the stimulation parameter comprises a duration of the treatment regimen (Ganguly ¶0062 “For example, an apparatus as described herein may automatically determine this stimulation range based on subjective feedback from the user. Concurrently or subsequently, parameters such as intensity, frequency, pulse duration as well as burst mode parameters may be varied.”).
Regarding claim 47, Claim 40 is anticipated by Ganguly. Ganguly further discloses wherein the wearable component comprises a strap having a first end and a second end configured for removable coupling to the first end for removable attachment to a limb of the user (Ganguly ¶0081 “The stimulator may be attached to or otherwise be connected to any or all parts of a watch or fitness band, including the display portion, one or more straps and/or latches, so long as the stimulator is placed near or on the skin or nerve.”).
Regarding claim 48, Claim 40 is anticipated by Ganguly. Ganguly further discloses wherein the electrical impulse is sufficient to stimulate one or more of the L4, L5, S2 and S2 sensory dermatomes. (Ganguly ¶0106 “Various nerves may be targeted for treat disease conditions or to enhance performance….cutaneous branches of L1-L4, S1-3. Sacral nerves include those supplying the S1-S3 dermatomes and the pudendal nerve. “).
Regarding claim 49, Claims 40 & 48 are anticipated by Ganguly. Ganguly further discloses wherein the pain is associated with diabetic peripheral neuropathy (Ganguly ¶0127 “For low back pain, including sciatica, lumbar radiculopathy and peripheral neuropathy, the device may stimulate nerves of the lower limb (e.g., S1-S5, L1-5”).
Regarding claim 50, Ganguly discloses an apparatus for providing therapy to a user (Ganguly ¶0040 “The biomarker monitor may be separate from the stimulator, or it may be coupled or combined with the stimulator. For example, the same electrodes applying electrical stimulation may be used to detect/sense electrical activity in the subject, including in the subject's peripheral nerve(s).”), the apparatus comprising: a wearable device comprising a first sensor for detecting an isometric muscle activity of the user (Ganguly ¶0040 “A biomarker monitor may include one or more electrodes for detecting biopotentials, e.g., electromyogram (EMG), electroocculogram (EOG), electroencephalogram (EEG), etc. For example, any of these apparatuses may include one or more electrical sensors (e.g., EMG sensors, etc.) as part of a biomarker monitor. “ where a a EMG sensor is designed to detect muscle activities such as isometric movements) and a second sensor for detecting a stride duration of the user (Ganguly ¶0036 “ny of these apparatuses, including the stimulator apparatus, may include one or more sensors, including but not limited to one or more motion sensors, position sensors (e.g., configured to determine the position of a portion of the subject's body), or the like.”)). ; an electrode configured for contacting an outer skin surface of user (Ganguly ¶0023 “ The electrical stimulation may be applied transdermally (e.g., through the skin) or via one or more implanted electrodes or adhesive patch electrodes (on the skin surface).”); an energy source coupled to the electrode (Ganguly ¶0053 “n FIG. 6A a wrist-band device that stimulates the radial, ulnar and median nerves in the wrist includes nerve stimulating electrodes, sensors for hand/limb movement, battery and related electronic circuitry, and wireless sensor for connectivity to a display and/or EEG biomarker signal from the brain”),, wherein the energy source is configured to generate at least one electrical impulse and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the user to a selected nerve in the user adjacent to, or near, the target location (Ganguly ¶0024 “Any of these methods may include placing a wearable transdermal stimulator onto one or more of the subject's arm and hand. For example, applying may comprise applying electrical stimulation from a wearable wrist band, a patch, or a smart glove.”); and a controller coupled to the wearable device (Ganguly ¶0008 “ a controller functionally coupled to the first input, wherein the controller is configured to apply an electrical stimulation to a peripheral nerve and to measure at least one of: a biomarker or a performance indicator from a task that activates the peripheral nerve to which the electrical stimulation was applied”) and configured to adjust a stimulation parameter of the electrical impulse based on either the isometric muscle activity (Ganguly ¶0034 “ adjust the stimulation parameters based on the measured biomarker, and transmit the adjusted stimulation parameters to the stimulator.”) or the stride duration of the user (Ganguly ¶0028 “Adjustment may be based on one or more indicators, as mentioned, including a biomarker (e.g., EEG signal) or performance metric. Any appropriate portion of the electrical stimulation parameters may be adjusted, including one or more of: intensity, current amplitude, frequency, duration, duty cycle, times/day, pulse duration, burst frequency, burst duration, or total treatment period. For example, adjusting the electrical stimulation may comprise increasing the intensity of stimulation.”; ¶0018 “ A performance metric may include a measure of overall movement (e.g., tremor) and/or coordinated movement ).
Regarding claim 53, Claim 50 is anticipated by Ganguly. Ganguly further discloses wherein the first sensor comprises an electromyography sensor (Ganguly ¶0009 “For example, a biomarker monitor may include one or more electrodes for detecting biopotentials, e.g., electromyogram (EMG), electroocculogram (EOG), electroencephalogram (EEG), etc. For example, any of these apparatuses may include one or more electrical sensors (e.g., EMG sensors, etc.)”).
Regarding claim 54, Claim 50 is anticipated by Ganguly. Ganguly further discloses wherein the stimulation parameter comprises one of an amplitude, a pulse width and a pulse frequency of the electrical impulses (Ganguly ¶0016 “The stimulator may include one or more controllers. For example, a controller may be configured to adjust the electrical stimulation by adjusting one or more of: intensity, current amplitude, frequency, duration, duty cycle, times/day, pulse duration, burst frequency, burst duration, or total treatment period.”).
Regarding claim 55, Claim 50 is anticipated by Ganguly. Ganguly further discloses wherein the electrical impulses are generated and transmitted according to a treatment regimen, wherein the stimulation parameter comprises a duration of the treatment regimen (Ganguly ¶0062 “For example, an apparatus as described herein may automatically determine this stimulation range based on subjective feedback from the user. Concurrently or subsequently, parameters such as intensity, frequency, pulse duration as well as burst mode parameters may be varied.”).
Regarding claim 56, Claim 50 is anticipated by Ganguly. Ganguly further discloses wherein the wearable component comprises a strap having a first end and a second end configured for removable coupling to the first end for removable attachment to a limb of the user (Ganguly ¶0081 “The stimulator may be attached to or otherwise be connected to any or all parts of a watch or fitness band, including the display portion, one or more straps and/or latches, so long as the stimulator is placed near or on the skin or nerve.”).
Regarding claim 57, Claim 50 is anticipated by Ganguly. Ganguly further discloses wherein the electrical impulse is sufficient to stimulate one or more of the L4, L5, S2 and S2 sensory dermatomes. (Ganguly ¶0106 “Various nerves may be targeted for treat disease conditions or to enhance performance….cutaneous branches of L1-L4, S1-3. Sacral nerves include those supplying the S1-S3 dermatomes and the pudendal nerve. “).
Regarding claim 58, Claim 50 is anticipated by Ganguly. Ganguly further discloses wherein the pain is associated with diabetic peripheral neuropathy (Ganguly ¶0127 “For low back pain, including sciatica, lumbar radiculopathy and peripheral neuropathy, the device may stimulate nerves of the lower limb (e.g., S1-S5, L1-5”).
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.
Claims 43 & 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Ganguly et al. (US Publication No. 20200061378) in view of Kong et al. (AU Publication No. 2017356223).
Regarding claim 43, Claims 40 & 42 are anticipated by Ganguly. Ganguly does not disclose wherein the controller is configured to adjust the stimulation parameter when a number of user strides exceeds a minimum threshold. Kong in a similar field of endeavor teaches wherein the controller is configured to adjust the stimulation parameter when a number of user strides exceeds a minimum threshold (Kong Page 3 Lines 35-38 “A key feature of the present invention is that the novel TENS device automatically tracks activity, gait, and balance functions and adjusts stimulation parameters according to biomarkers derived from the activity, gait, and balance measures obtained from the user.”; Page 11 Lines 14-18 “A walk segment is a sequence of consecutive strides when the WalkNow status remains true. A qualified walk segment is a walk segment whose stride characteristics meet certain criteria, such as the number of strides exceed a minimum threshold. Because the walking environment may influence gait variability, the daily distribution of CoV (percentile values) is updated and reported to the user whenever a qualified walk segment becomes available. “).
Before the effective filing date, one of ordinary skill in the art would have thought to integrate the embodiments of Ganguly with methods to adjust the stimulation parameter when a number of user strides exceeds a minimum threshold, as taught in Kong, for the purpose of creating a device which can adjust stimulation to provide the most effective treatment for an ailment by monitoring it’s efficacy through changes in activity.
Regarding claim 51, claim 50 is anticipated by Ganguly. Ganguly does not disclose wherein the second sensor is configured to detect a heel strike event. Kong in a similar field of endeavor teaches wherein the second sensor is configured to detect a heel strike event. (Kong Page 17 Lines 1-3 “Swing event identification unit 518 (Fig. 12) identifies components in the acceleration or gyroscope data waveforms characteristic to leg swings. The timing of events like toe-off and heel strike associated with each leg swing is extracted from the waveform features.”).
Before the effective filing date, one of ordinary skill in the art would have thought to integrate the embodiments of Ganguly with a sensor that is configured to detect a heel strike event, as taught in Kong, for the purpose of creating a device which can monitor changes in patient activity such as changes in walking patterns.
Regarding claim 52, claim 50 is anticipated by Ganguly. Ganguly does not disclose wherein the second sensor is configured to detect a toe-off event. Kong in a similar field of endeavor teaches wherein the second sensor is configured to detect a toe-off event. (Kong Page 17 Lines 1-3 “Swing event identification unit 518 (Fig. 12) identifies components in the acceleration or gyroscope data waveforms characteristic to leg swings. The timing of events like toe-off and heel strike associated with each leg swing is extracted from the waveform features.”).
Before the effective filing date, one of ordinary skill in the art would have thought to integrate the embodiments of Ganguly with a sensor that is configured to detect a toe-off event, as taught in Kong, for the purpose of creating a device which can monitor changes in patient activity such as changes in walking patterns.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN FEDORKY whose telephone number is (571)272-2117. The examiner can normally be reached M-F 9:30-4:30.
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796