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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/02/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 06/09/2026 have been fully considered but are not persuasive.
Applicant agues, “Page describes repositioning electrode 120 based on a measured heart rate change in response to electrical stimulation (see [0277]). Page's method involves actively stimulating the patient and then observing a physiological response to that stimulation… Page's method is a stimulation-response feedback loop, which is fundamentally different from the claimed method of using a passively detected heart pulse together with a known electrode position relative to the cervical vagus nerve….. Schepis describes repositioning an electrode based solely on heart rate (see [0056]). However, Schepis uses heart rate alone. Schepis does not teach or suggest using a position of the electrode relative to a cervical branch of a vagus nerve as a distinct, separate input for repositioning. The claims require both the heart pulse and the electrode's position relative to the cervical vagus nerve - Schepis provides only one of these two required inputs.”
Examiner respectfully disagrees. As stated below, the limitation “repositioning the electrode solely based on the heart pulse and a position of the electrode relative to a cervical branch of a vagus nerve” is interpreted as confirming a target location of a cervical branch of a vagus nerve solely based on heart rate and an indication of the stimulator relative to the heart pulse, as disclosed by Applicant’s specification [0165-0166, 0170]. Further, under broadest reasonable interpretation, an indication of the stimulator relative to the heart pulse is a sign or piece of information that confirms the target location based on the heart pulse, for instance, a change in the heart pulse or a magnitude of heart pulse that confirms optimal location of the electrode.
Regarding the above recited limitations, Page discloses repositioning the electrode based on
the heart pulse ([0277]: heart rate change can be used to indicate alignment of electrode 120) and
a position of the electrode relative to a vagus nerve ([0277]: heart rate change is indicative of placement of the stimulation device in alignment with targeted nervous structure; [0017]: targeted nervous structure includes a vagus nerve).
Page fails to disclose repositioning the electrode based solely on
the heart pulse and
a position of the electrode relative to a cervical branch of a vagus nerve.
Schepis teaches modulating neural tissue to treat pain [0002] and teaches repositioning an electrode’s [0056] position based solely on heart rate ([0056]: use of “and/or” implies only an “or” being an option, i.e., only heart rate is used instead of cutaneous blood flow change or a skin conductance change as well) and a position of the electrode relative to a vagus nerve (as discussed above, position of the electrode relative to a target structure is interpreted as indication of the position of the stimulator relative to the heart pulse within the patient, which is taught by Schepis: [0056-0057]: heart rate increase indicates placement of the electrode in a target area, which provides an indication of the electrode relative to the heart pulse; [0103]: targeted nervous structures may include vagus nerve).
Schepis further teaches that multiple parameters may be used to adjust a position of the electrode [0052], including heart rate [0056], where changes in heart rate can be indicative of position [0056-0057].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve within a patient yielded by the proposed combination, to provide repositioning the electrode based solely on the heart pulse and a position of the electrode relative to a vagus nerve, as taught by Schepis, because an increase in heart rate can be used to confirm electrode position and is indicative of placement, among other parameters.
Regarding the limitation, “… to a cervical branch of a vagus nerve,” Zitnick teaches
providing vagus nerve stimulation [0016] for treatment [0016] and teaches
applying an electrical impulse from an electrode (fig. 2: 200; [0027, 0060]) transcutaneously [0027, 0060] through an outer skin surface of a patient [0027] to a cervical branch of a vagus nerve [0027, 0068] to modulate the cervical branch of the vagus nerve [0027, 0068].
Zitnick further teaches that stimulating the cervical branch of the vagus nerve activates a cholinergic anti-inflammatory pathway (CAP) [0068], which is used to treat diseases characterized by dysregulated inflammation [0017].
The proposed combination would further yield repositioning the electrode based solely on the heart pulse and a position of the electrode relative to a cervical branch of a vagus nerve, since the cervical branch of a vagus nerve would be the new target for stimulation, therefore, the proposed combination would need to confirm a position of the electrode relative to a cervical branch of a vagus nerve.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve within a patient yielded by the proposed combination, to provide applying an electrical impulse from the electrode transcutaneously through the outer skin surface of the patient to a cervical branch of the vagus nerve to modulate the cervical branch of the vagus nerve, as taught by Zitnick, because stimulating the cervical branch of the vagus nerve activates a cholinergic anti-inflammatory pathway (CAP), which is used to treat diseases characterized by dysregulated inflammation.
Thus, the proposed combination yields the above recited limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1,3-5,8-25,27-28 and 31-45 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.
In re claim 1, the limitation, “repositioning the electrode solely based on the heart pulse and a position of the electrode relative to a cervical branch of a vagus nerve” is unclear. Specifically, it is unclear regarding whether the position of the electrode relative to a cervical branch of a vagus nerve is an already known position that is confirmed when the electrode is located at said position, or if the electrode position is confirmed once a target location is confirmed based on an indication of the stimulator relative to the heart pulse.
For instance, Applicant’s specification discloses using heart pulse to reposition stimulator 300 [0170] via sensor 380 (fig. 4; [0170], and discloses that stimulator 300 may also include a position indicator 390 (fig. 4: 390; [0165]), which confirms target location based on an indication of the stimulator relative to the heart pulse [0165]. Further, Applicant’s specification provides an example wherein an indication of the stimulator relative to the heart pulse is based on a magnitude of the heart pulse [0165] associated with optimal positioning [0166].
For examination purposes, the limitation “repositioning the electrode solely based on the heart pulse and a position of the electrode relative to a cervical branch of a vagus nerve” is interpreted as confirming a target location of a cervical branch of a vagus nerve solely based on heart rate and an indication of the stimulator relative to the heart pulse, as disclosed by Applicant’s specification [0165-0166, 0170].
Further, under broadest reasonable interpretation, an indication of the stimulator relative to the heart pulse is a sign or piece of information that confirms the target location based on the heart pulse, for instance, a change in the heart pulse or a magnitude of heart pulse that confirms optimal location of the electrode.
In re claim 25, regarding the limitation, “a controller for determining a target location on the outer skin surface for the electrode solely based on the heart pulse and a position of the electrode relative to a cervical branch of a vagus nerve”, see in re claim 1 above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 8-16, 18-19, 25, 28, 31-37, and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Page et al (US 2020/0269046) in view of Po et al. (US 2020/0324105) in view of Schepis et al. (US 2020/0179698) in view of Zitnick et al. (US 2015/0241447).
In re claim 1, Page discloses a method for stimulating a nerve within a patient [0001], the method comprising:
determining a target location on an outer skin surface of a neck ([0177]: targeted nervous structure may include nerves located on a neck) of the patient [0177]
adjacent to ([0017]: vagus nerve stimulation would be adjacent to a carotid artery),
near ([0017]: vagus nerve stimulation would be near the carotid artery), or
overlying,
a carotid artery ([0175]: target location is at an outer surface of the patient’s skin overlying the selected nerve which may be near or adjacent to a carotid artery [0017]; [0277]: target location is determined based on heart rate change; [0275]);
positioning an electrode in contact with the outer skin surface at, or near, the target location ([0277-0278]: the position of the electrode 120 is adjusted until the correct position is confirmed near the target location based on measured heart rate change indicating alignment of the electrode with the target location; fig. 2);
detecting a heart pulse of the patient ([0277]: heart rate change measured) at a remote location (fig. 19: D; [0257]: element D identifies feedback from a heart rate monitor);
repositioning the electrode based on
the heart pulse ([0277]: heart rate change can be used to indicate alignment of electrode 120) and
a position of the electrode relative to a vagus nerve ([0277]: heart rate change is indicative of placement of the stimulation device in alignment with targeted nervous structure; [0017]: targeted nervous structure includes a vagus nerve); and
applying an electrical impulse from the electrode transcutaneously through the outer skin surface of the patient to a vagus nerve [0017, 0162] to modulate the vagus nerve
([0281-0282]: once the electrodes are secured in position, electrical stimulation is delivered to the treatment site; [0175]: transcutaneous application is applied adjacent an outer surface of the patient’s skin; [0162]: targeted nervous structure may comprise the vagus nerve; [0017, 0183]).
Page fails to disclose:
detecting a heart pulse of the patient at the target location;
repositioning the electrode based solely on
the heart pulse and
a position of the electrode relative to a cervical branch of a vagus nerve; and
applying an electrical impulse from the electrode transcutaneously through the outer skin surface of the patient to a cervical branch of the vagus nerve to modulate the cervical branch of the vagus nerve.
Regarding the limitation, “detecting a heart pulse of the patient at the target location”, Po teaches an analogous method for stimulating a vagus nerve [0009], comprising detecting a heart purse of the patient at a target location ([0084]: ear device comprises a reflective pulse oximeter sensor that measures heart rate to determine if a threshold value of HRV is met to warrant stimulation; [0009]: electrode in ear device starts stimulation, therefore the heart pulse is detected at a target location).
Po further teaches measuring heart rate and providing stimulation to a subject at the same target location [0009], by having the sensor that detects heart rate and the electrode which provides stimulation to be in the same ear device [0009], resulting in simplicity and easier packaging since the device wouldn’t require extra or additional components that are located away from the electrode.
The proposed combination would be to modify Page by providing wherein the heart rate monitor of Page is located at the same position as the electrode 120 of Page, as taught by Po, which teaches the electrode and heart rate sensor to be in the same location.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the location where the heart pulse of the patient is detected in Page, to be measured at the target location where the electrode provides stimulation, as taught by Po, because doing so will provide simplicity and easier packaging since the device wouldn’t require extra or additional components that are located away from the electrode.
The proposed combination would yield detecting a heart pulse of the patient at the target location, since Page teaches repositioning the alignment of electrode 120 with the target nervous structure based on heart rate (Page: [0277]), and the modification of Page in view of Po would result in the heart pulse being measured at the target location.
Regarding the limitation, “repositioning the electrode based solely on the heart pulse and a position of the electrode relative to…a vagus nerve”, Schepis teaches modulating neural tissue to treat pain [0002] and teaches repositioning an electrode’s [0056] position based solely on heart rate ([0056]: use of “and/or” implies only an “or” being an option, i.e., only heart rate is used instead of cutaneous blood flow change or a skin conductance change as well) and a position of the electrode relative to a vagus nerve (as discussed above, position of the electrode relative to a target structure is interpreted as indication of the position of the stimulator relative to the heart pulse within the patient, which is taught by Schepis: [0056-0057]: heart rate increase indicates placement of the electrode in a target area, which provides an indication of the electrode relative to the heart pulse; [0103]: targeted nervous structures may include vagus nerve).
Schepis further teaches that multiple parameters may be used to adjust a position of the electrode [0052], including heart rate [0056], where changes in heart rate can be indicative of position [0056-0057].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve within a patient yielded by the proposed combination, to provide repositioning the electrode based solely on the heart pulse and a position of the electrode relative to a vagus nerve, as taught by Schepis, because an increase in heart rate can be used to confirm electrode position and is indicative of placement, among other parameters.
Regarding the limitation,
“applying an electrical impulse from the electrode transcutaneously through the outer skin surface of the patient to a cervical branch of the vagus nerve to modulate the cervical branch of the vagus nerve”, Zitnick teaches
providing vagus nerve stimulation [0016] for treatment [0016] and teaches
applying an electrical impulse from an electrode (fig. 2: 200; [0027, 0060]) transcutaneously [0027, 0060] through an outer skin surface of a patient [0027] to a cervical branch of a vagus nerve [0027, 0068] to modulate the cervical branch of the vagus nerve [0027, 0068].
Zitnick further teaches that stimulating the cervical branch of the vagus nerve activates a cholinergic anti-inflammatory pathway (CAP) [0068], which is used to treat diseases characterized by dysregulated inflammation [0017].
The proposed combination would further yield repositioning the electrode based solely on the heart pulse and a position of the electrode relative to a cervical branch of a vagus nerve, since the cervical branch of a vagus nerve would be the new target for stimulation, therefore, the proposed combination would need to confirm a position of the electrode relative to a cervical branch of a vagus nerve.
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve within a patient yielded by the proposed combination, to provide applying an electrical impulse from the electrode transcutaneously through the outer skin surface of the patient to a cervical branch of the vagus nerve to modulate the cervical branch of the vagus nerve, as taught by Zitnick, because stimulating the cervical branch of the vagus nerve activates a cholinergic anti-inflammatory pathway (CAP), which is used to treat diseases characterized by dysregulated inflammation.
In re claim 3, the proposed combination yields (all mapping directed to Page unless otherwise stated) further comprising transmitting an ultrasound signal through the outer skin surface ([0276]: ultrasound used initially to place the electrode on an outer surface of the patient’s skin proximate the target neural structure).
In re claim 4, the proposed combination in re claim 1 yields moving a pulse sensor across the outer skin surface until a heart pulse is detected at the target location (Page: [0277]: alignment of electrode 120 with the target nervous structure may include a physiological response such as heart rate, i.e. the electrode may be moved around until there is a heart pulse detected at the target location that is indicative of the stimulation device being aligned with the target nervous structure).
In re claim 5, the proposed combination fails to yield further comprising providing an alert when the heart pulse is detected.
Po teaches
providing an alert associated with the magnitude of the heart pulse when the heart pulse is detected ([0046]: when heart rate is measured, the magnitude is monitored to determine if a person is experiencing an autonomic nervous system dysfunction, which causes an alert to be outputted; [0081]),
wherein the alert comprises a visual [0081] or audial signal [0081].
Po further teaches that heart rate can be used to determine if a person is experiencing autonomic nervous system dysfunction [0046], and if they are, then an alert is sent to start stimulation of the vagus nerve [0046], which restores balance to autonomic nervous system (ANS) activity [0026, 0009].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide an alert associated with the magnitude of the heart pulse when the heart pulse is detected, wherein the alert comprises a visual or audial signal, as taught by Po, because monitoring heart pulse can be used to determine if a person is experiencing an autonomic nervous system (ANS) dysfunction, and if they are, then an alert is sent to start stimulation of the vagus nerve, which restores balance to ANS activity.
In re claim 8, the proposed combination yields (all mapping directed to Page unless otherwise stated)
wherein the electrode is disposed on an outer surface of a stimulator housing ([0178]: electrode 120 located on contact surface of a housing of the stimulation device) and
further comprising positioning a sensor of the housing (see the proposed combination yielded in re claim 1 regarding the heart rate sensor being positioned with the electrode, resulting in the sensor being part of the housing) against the outer skin surface of the patient ([0178]: housing sized and configured for placement adjacent an outer surface of patient’s skin).
In re claim 9, the proposed combination fails to yield wherein the sensor comprises an infrared sensor.
Po teaches wherein a sensor (fig. 2: 212; [0057]) comprises an infrared sensor ([0034]: reflective pulse oximeter (also interpreted as a photoplethysmography sensor) comprises an optical emitter which shines an infrared light on a person’s skin and a photodetector that picks up the scattered light).
Po further teaches that the reflective pulse oximeter can be used to detect abnormalities in heart rate variability (HRV) that are indicative of autonomic nervous system dysfunction [0058], indicating the need for stimulation to be delivered to the patient [0009].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide wherein the sensor comprises an infrared sensor, as taught by Po, because doing so will allow for the reflexive pulse oximeter to be used to detect abnormalities in HRV, which indicates autonomic nervous system dysfunction and the need for stimulation.
In re claim 10, the proposed combination in re claim 9 above yields wherein the sensor comprises a light source configured to transmit light through the outer skin surface.
In re claim 11, the proposed combination in re claim 1 above yields wherein the sensor comprises a photoplethysmography (PPG) sensor (Po: [0034]: reflective pulse oximeter is a photoplethysmography (PPG) sensor).
In re claim 12, the proposed combination in re claim 1 yields further comprising detecting a magnitude of the heart pulse (Page: [0262]: heart-rate monitor collects electrocardiogram signals corresponding to patient’s heart rate which would have a magnitude).
In re claim 13, regarding the limitation, “further comprising providing an alert associated with the magnitude of the heart pulse”, see the proposed combination yielded in re claim 5 above.
In re claim 14, regarding the limitation, “wherein the alert comprises a visual or audial signal”, see the proposed combination yielded in re claim 5 above.
In re claim 15, the proposed combination yields (all mapping directed to Page unless otherwise stated) further comprising attaching the one or more electrodes to the outer skin surface of a neck of the patient [0178].
In re claim 16, the proposed combination yields (all mapping directed to Page unless otherwise stated) wherein the electrodes are coupled to an energy source (power source 180; [0254]) via one or more leads ([0256]: electrodes 120 are coupled to controller 130 through a wired connection from electrical lead L; [0181]: controller 130 can be coupled with power source 180 through a wire i.e. another lead).
In re claim 18, the proposed combination yields (all mapping directed to Page unless otherwise stated)
wherein the electrodes are part of a housing ([0178]: electrode 120 is provided on the contact surface of a housing which facilitates placement of the electrode) and
wherein the energy source is housed within the housing ([0181]: power source 180 can be within the same housing).
In re claim 19, the proposed combination yields (all mapping directed to Page unless otherwise stated) further comprising attaching a patch to the outer skin surface of a neck of the patient ([0239]: patch electrode can be positioned on a patient’s neck; [0178]; [0138]: different features and embodiments may be combined with one another), wherein the patch comprises one or more electrodes [0239].
In re claim 25, Page discloses a device (fig. 1: 100) for stimulating a nerve within a patient [0001], the device comprising:
a heart pulse sensor [0277] for detecting a heart pulse on an outer skin surface of the patient ([0257]: element D comprises of a heart rate monitor; fig. 19: D);
an electrode configured for contacting the outer skin surface (see in re claim 1 above); and
a controller [0009] for determining a target location on the outer skin surface for the electrode based on the heart pulse ([0277]: alignment of electrode 120 is determined using a physiological response such as a heart rate change; [0009]) and a position of the electrode relative to a vagus nerve (see in re claim 1 above); and
an energy source (power source 180; [0254]) coupled to the electrode (fig. 1),
wherein the energy source is configured
to generate at least one electrical impulse ([0282]: power source 180 supplies electrical energy) and
to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the patient to a vagus nerve (see in re claim 1 above) in the patient adjacent to, or near, the target location (see in re claim 1 above).
Page fails to disclose
a heart pulse sensor for detecting a heart pulse on an outer skin surface of a neck of the patient adjacent to, near, or overlying, a carotid artery;
a controller for determining a target location on the outer skin surface for the electrode solely based on the heart pulse and a position of the electrode relative to a cervical branch of a vagus nerve; and
wherein the energy source is configured…to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the patient to a cervical branch of a vagus nerve in the patient adjacent to, or near, the target location.
Regarding the limitations,
“a heart pulse sensor for detecting a heart pulse on an outer skin surface of a neck of the patient adjacent to, near, or overlying, a carotid artery;
a controller for determining a target location on the outer skin surface for the electrode solely based on the heart pulse and a position of the electrode relative to a cervical branch of a vagus nerve; and
wherein the energy source is configured…to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the patient to a cervical branch of a vagus nerve in the patient adjacent to, or near, the target location”,
see the proposed combination yielded in re claim 1 above.
In re claim 28, the proposed combination in re claim 5 yields, “further comprising an indicator coupled to the heart pulse sensor for providing an alert when the heart pulse is detected”.
In re claim 31, regarding the limitations, “further comprising a stimulator housing, wherein the electrode is disposed on an outer surface of the stimulator housing and the sensor is coupled to the stimulator housing”, see in re claim 8 above.
In re claim 32, regarding the limitation, “wherein the heart pulse sensor comprises an infrared sensor”, see the proposed combination yielded in re claim 9 above.
In re claim 33, regarding the limitation, “wherein the sensor comprises a light source configured to transmit light through the outer skin surface”, see the proposed combination yielded in re claim 10 above.
In re claim 34, regarding the limitations, “wherein the sensor comprises a photoplethysmography (PPG) sensor”, see the proposed combination yielded in re claim 11 above.
In re claim 35, regarding the limitation, “wherein the heart pulse sensor is configured to detect a magnitude of the heart pulse”, see the proposed combination yielded in re claim 12 above.
In re claim 36, regarding the limitation, “further comprising an indicator coupled to the heart pulse sensor configured to provide an alert associated with the magnitude of the heart pulse”, see the proposed combination yielded in re claim 13 above.
In re claim 37, regarding the limitation, “wherein the alert comprises a visual or audial signal”, see the proposed combination yielded in re claim 14 above.
In re claim 39, regarding the limitation, “wherein the electrode is configured for attachment to the outer skin surface of a neck of the patient”, see in re claim 15 above.
In re claim 40, regarding the limitation, “further comprising a housing, wherein the energy source is housed within the housing and the electrode is attached to, or incorporated into, the housing”, see in re claim 18 above.
In re claim 41, regarding the limitation, “further comprising a patch having an adhesive surface configured for attachment to the outer skin surface of a neck of the patient, wherein the electrode is housed within the patch”, see in re claim 19 above.
Claims 17, 21-22, 38, and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Page et al (US 2020/0269046) in view of Po et al. (US 2020/0324105) in view of Schepis et al. (US 2020/0179698) in view of Zitnick et al. (US 2015/0241447) in view of Errico et al. (US 2014/0330335).
In re claim 17, the proposed combination fails to yield further comprising wirelessly transmitting the electrical impulse to the one or more electrodes.
Errico teaches wirelessly transmitting the electrical impulse to the one or more electrodes [0062, 0180].
Errico further teaches that having components communicate wirelessly avoids the inconvenience and distance limitations that comes with using cables [0180].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide wirelessly transmitting the electrical impulse to the one or more electrodes, as taught by Errico, because doing so avoids the inconvenience and distance limitations that comes with using cables.
In re claim 21, the proposed combination yields (all mapping directed to Page unless otherwise stated) wherein the electrical impulse comprises bursts of pulses [0034],
with each burst having a frequency of about 1 to about 100 bursts per second ([0220]: “a burst frequency from about 0.01 Hz to about 50 Hz”).
The proposed combination fails to yield wherein each pulse has a duration of about 50 to about 1000 microseconds in duration.
Errico teaches wherein an electrical impulse comprises bursts of pulses [0059], with
each burst having a frequency of about 15 to about 50 bursts per second [0059] and
each pulse has a duration of about 20 to about 1000 microseconds in duration [0059].
Errico further teaches that the pulse width can be selected to influence the therapeutic result [0140], and various pulse width ranges can be selected [0140].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide wherein each pulse has a duration of about 50 to about 1000 microseconds in duration, as taught by Errico, because the pulse duration can be selected as needed to influence the therapeutic result.
Additionally, even if Errico fails to explicitly teach wherein each pulse has a duration of about 50 to about 1000 microseconds in duration, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein each pulse has a duration of about 50 to about 1000 microseconds in duration, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In re claim 22, the proposed combination fails to yield wherein
the bursts each comprise about 2 to 20 pulses and
the bursts are separated by an inter-burst period that comprises zero pulses.
Errico teaches wherein
the bursts each comprise about 2 to 20 pulses [0059] and
the bursts are separated by an inter-burst period that comprises zero pulses ([0059]: “burst followed by a silent inter-burst interval”; [0144]).
Errico further teaches that different stimulation parameters such as pulses per burst and inter-burst interval can be adjusted to provide a selective physiological response to the patient [0061], that avoids producing pain and avoids stimulating nerves other than the targeted nerve [0061].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide wherein the bursts each comprise about 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulses, as taught by Errico, because adjusting the stimulation parameters provides the patient with a selective physiological response that prevents nerves other than the targeted nerve from being stimulated, as well as preventing pain.
Additionally, even if Errico fails to explicitly teach wherein the bursts each comprise about 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulse, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the bursts each comprise about 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulse, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In re claim 38, the proposed combination fails to yield wherein the energy source is wirelessly coupled to the electrode.
Errico teaches wherein an energy source (fig. 7: 320; [0132]) is wirelessly coupled to the electrode ([0180]: components of the controller and stimulator housing communicate wirelessly; [0062, 0180])
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide wherein the energy source is wirelessly coupled to the electrode, as taught by Errico, for substantially the same reasons as discussed in re claim 17 above.
In re claim 43, regarding the limitation, “wherein the electrical impulse comprises bursts of pulses, with each burst having a frequency of about 1 to about 100 bursts per second and each pulse has a duration of about 50 to about 1000 microseconds in duration”, see in re claim 21 above.
In re claim 44, regarding the limitation, “wherein the bursts each comprise about 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulses”, see in re claim 22 above.
In re claim 45, the proposed combination yields (all mapping directed to Page unless otherwise stated) wherein the stimulation device is configured for wireless coupling to a mobile device ([0261]: user interface 170 may be provided on a phone and may be wirelessly coupled to the stimulation device).
The proposed combination fails to yield
wherein the stimulator housing is configured for wireless coupling to a mobile device,
further comprising a downloadable software application configured to
receive a electrical signal and
provide an alert on the mobile device.
Errico teaches
wherein the stimulator housing is configured for wireless coupling to a mobile device [017],
further comprising a downloadable software application [0157] configured to
receive a electrical signal [0054, 0157] and
provide an alert on the mobile device ([0208]: stimulator communicates with mobile phone to alert if there is an error with the stimulator).
Errico further teaches that the patient can initiate the stimulation session using the mobile phone that [0204], and that the mobile app can be used to alert the patient that stimulation is attempted at the wrong nerve, or if the device is held improperly [0208].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in yielded by the proposed combination, to provide wherein the stimulator housing is configured for wireless coupling to a mobile device, further comprising a downloadable software application configured to receive a electrical signal and provide an alert on the mobile device, as taught by Errico, because doing so will allow for the patient to control the stimulator from the mobile app, and to also the mobile app to be alerted if stimulation is being attempted at the wrong nerve or if the stimulator is being held improperly.
Claims 20 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Page et al (US 2020/0269046) in view of Po et al. (US 2020/0324105) in view of Schepis et al. (US 2020/0179698) in view of Zitnick et al. (US 2015/0241447) in view of Page et al (US 2020/0269046).
In re claim 20, the proposed combination fails to yield wherein the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz.
Page teaches wherein the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz [0031, 0204].
Page further teaches that a “a high-frequency stimulation applied at 5-20 kHz at up to 60 mA for a few minutes can be applied to invoke an inhibition of nervous signaling” [0203], which can be used to invoked sufficient pain inhibition response [0203]. Page also teaches that various stimulation frequency ranges can be applied [0204], and higher frequency components (frequency greater than 2 KHz), enables blocking of nervous signaling [0204].
At the time the instant application was filed it would be obvious to try to provide wherein the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz. Furthermore, when there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. KSR, 550 U.S. at 421, 82 USPQ2d at 1397, especially since the claimed frequency is not disclosed as being crucial or unexpected. Further, a person of ordinary skill in the art would consider a frequency that would not harm the patient, which would include a frequency of about 1 kHz to about 20 kHz. Additionally, Page teaches that various stimulation frequency ranges can be applied, and that providing a high frequency range (for instance 5-20KHz) invokes an inhibition of nervous signal, which inhibits pain.
Even if the proposed combination fails to yield wherein the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide wherein the proposed combination yields wherein the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 42, regarding the limitation, “wherein the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz”, see in re claim 20 above.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Page et al (US 2020/0269046) in view of Po et al. (US 2020/0324105) in view of Schepis et al. (US 2020/0179698) in view of Zitnick et al. (US 2015/0241447) in view of Errico et al. (US 2014/0330335) in view of Vogel et al. (US 2016/0278647).
In re claim 23, the proposed combination fails to yield further comprising wirelessly transmitting an electrical signal associated with the heart pulse to a mobile device and providing an alert on the mobile device when the heart pulse is detected.
Regarding the limitations, “wirelessly transmitting an electrical signal associated with the heart pulse to a mobile device”, Errico teaches
wirelessly transmitting an electrical signal associated with an imaging of spots of dye to a mobile device ([0054, 0157]; [0165]: imaging with spots of dyes with rear camera used to reposition the stimulation device where stimulation is applied, therefore the “the waveform of the signal that is to be applied to the patient” [0054] will be based off of the imaging of the spots of dye),
downloading a software application onto the mobile device [0054],
wherein the software application is configured to
receive the electrical signal [0054].
Errico further teaches that the patient can initiate the stimulation session using the mobile phone that [0204], and that the mobile phone can receive the electrical signal that will be applied to the patient and then provide the electrical signal to the electrodes [0054].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide wirelessly transmitting an electrical signal associated with the heart pulse to a mobile device and to download a software application onto the mobile device that receives the electrical signal, as taught by Errico, because doing so will allow for the patient to control the stimulator from the mobile app, and allow the mobile phone to send the electrical signal to the electrodes.
Regarding the limitations, “wirelessly transmitting an electrical signal associated with the heart pulse to a mobile device,” the proposed combination in re claim 1 above yields wirelessly transmitting an electrical signal associated with the heart pulse to a mobile device, specifically, the electrical signal transmitted will be associated with the heart pulse, since a heart rate change is used to determine correct placement of electrode 120 (Page: [0277]), which provides an electrical signal to the target location (Page: [0183]).
Regarding the limitations, “providing an alert on the mobile device when the heart pulse is detected”, Vogel teaches an analogous wearable sensor device (fig. 2: 210) that detects heart rate information [0029], and teaches
a mobile device (230),
a software application downloaded onto the mobile device [0029]
wherein the software application is configured to provide an alert on a mobile device when the heart pulse is detected [0029].
Vogel further teaches that the mobile device can either be provided an alert that indicates whether or not the wearable device is aligned properly based on whether the detected heart rate corresponds with expected values [0027, 0036]. Vogel further teaches that if misalignment is detected, then the user can be instructed to adjust the position of the wearable device [0036] so the heart rate sensor can collect accurate heart rate measurements [0036].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide wherein the software application is configured to provide an alert on the mobile device when the heart pulse is detected, as taught by Vogel, because doing so will provide the patient with an indication of whether or not the wearable device is positioned properly so they can adjust the position as needed to obtain accurate heart rate measurements.
In re claim 24, the proposed combination in re claim 23 above yields further comprising
downloading a software application onto the mobile device,
wherein the software application is configured to
receive the electrical signal and
provide the alert on the mobile device.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Page et al (US 2020/0269046) in view of Po et al. (US 2020/0324105) in view of Schepis et al. (US 2020/0179698) in view of Zitnick et al. (US 2015/0241447) in view of Jarvik et al. (US 2010/0087728).
In re claim 27, the proposed combination fails to yield wherein the heart pulse sensor comprises an ultrasound probe.
Jarvik teaches providing treatment to identified target sites [0003] wherein a heart pulse sensor [0065] comprises an ultrasound probe ([0065]: ultrasound probe may be used to detect heart rate).
Jarvik further teaches that an ultrasound probe may be used to various biological responses [0065], and that it can be used to “provide imaging, palpation, mapping, identification and treatment” to selected target sites [0065].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the method for stimulating a nerve in a patient yielded by the proposed combination, to provide wherein the heart pulse sensor comprises an ultrasound probe, as taught by Jarvik, because doing so will allow for the ultrasound probe to provide imaging, palpation, mapping, identification and treatment to selected target sites, and can be used to detect various biological responses.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Faltys (US 2010/0125304) discloses methods and systems for selecting an optimum position of a stimulation electrode (abstract), wherein changes in heart rate may be used to confirm position relative to a portion of a vagus nerve [0019].
Contact
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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