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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 17, 2025 has been entered.
Response to Arguments
In regard to Applicant’s arguments filed on November 17, 2025, the applicant states that claims 7 and 11 were not rejected in view of any prior art. The examiner would like to note that the rejection of claims 7 and 11 were inadvertently omitted from the final rejection. With respect the 35 USC 103 rejections, these rejections have been fully considered and are persuasive. Therefore, the previous rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection have been made in view of applicant’s amendments as can be further seen below.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-5, 7, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0361544 A1 to Oron et al. (hereinafter “Oron”).
Regarding claim 1, Oron teaches:
A leadless neurostimulation device/ implant system (see abstract, line 1 and fig. 4, 102) comprising:
a header unit (see annotated fig. 4, 24 below) comprising:
at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device, the at least one primary electrode comprising a cathode (see annotated fig. 4 below), and a housing (see para 0137-0140) comprising:
a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode, the secondary electrode comprising an anode (see annotated fig. 4 below and para 0137- 0146 – because the current alternates between both electrodes, both of the electrodes will function as an anode or cathode during stimulation),
a footer coupled to the housing opposite of the header unit (see annotated fig. 4 below);
one or more sensors on an exterior surface of the housing, aligned linearly with the primary electrode and the secondary electrode (see annotated fig. 4 below), and a controller (see fig. 5, 136 and para 0179)
configured to operate in a closed-loop to:
transmit an electrical stimulation signal between the primary electrode to the secondary electrode to provide electrical stimulation therapy to a tibial nerve of a patient (see para 0135-0136, and para 0154);
measure a physiologic parameter (blood flow) using the one or more sensors, the primary electrode, or the secondary electrode, in response to transmission of the electrical stimulation therapy, and adjust/calibrate one or more parameters of the electrical stimulation signal based on the measured physiologic parameter (para 0164, para 0167, and para 0172).
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Regarding claim 4, Oron teaches:
The leadless neurostimulation device of claim 1, further comprising one or more sensors positioned along an exterior surface of the housing or the footer (see annotated fig. 4 above, 104 and 110, and para 0172 ), wherein the controller is configured to measure the physiologic parameter (blood perfusion or blood flow) with the one or more sensors (see para 0172: “Implant 102 comprises at least one sensor, configured to detect a respective factor indicative of local blood supply (e.g., indicative of blood perfusion to the tissue in which the implant is disposed, or indicative of blood flow through a nearby artery). For illustrative purposes, implant 102 is shown as having a first sensor 104 and a second sensor 110”).
Regarding claim 5, Oron teaches:
The leadless neurostimulation device of claim 1, wherein the controller (see fig. 5, 136 and para 0179) is configured to measure the physiologic parameter (blood perfusion or blood flow) with one or more of:
the one or more sensors, the primary electrode, or the secondary electrode (para 0172 and para 0178-0179).
Regarding claim 7, Oron teaches:
The leadless neurostimulation device of claim 5, wherein at least two sensors of the plurality of sensors are aligned linearly with the primary electrode and the secondary electrode (see annotated fig. 4 below).
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Regarding claim 11, Oron teaches:
A leadless neurostimulation device/ implant system (see abstract, line 1 and fig. 4, 102) comprising:
a header unit (see annotated fig. 4, 24 below) comprising:
at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device, the at least one primary electrode comprising a cathode (see annotated fig. 4 below), and a housing (see para 0137-0140) comprising:
a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode, the secondary electrode comprising an anode (see annotated fig. 4 below and para 0137- 0146 – because the current alternates between both electrodes, both of the electrodes will function as an anode or cathode during stimulation),
a footer coupled to the housing opposite of the header unit (see annotated fig. 4 below);
one or more sensors on an exterior surface of the housing, aligned linearly with the primary electrode and the secondary electrode (see annotated fig. 4 below), and one or more sensors on an exterior surface of the housing along a perimeter edge of the neurostimulation/ electrostimulator implant (see annotated fig. 4 below)
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and a controller (see fig. 5, 136 and para 0179)
configured to operate in a closed-loop to:
transmit an electrical stimulation signal between the primary electrode to the secondary electrode to provide electrical stimulation therapy to a tibial nerve of a patient (see para 0135-0136, and para 0154);
measure a physiologic parameter (blood flow) using the one or more sensors, the primary electrode, or the secondary electrode, in response to transmission of the electrical stimulation therapy, and adjust/calibrate one or more parameters of the electrical stimulation signal based on the measured physiologic parameter ( para 0164, para 0167, and para 0172).
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Regarding claim 12, Oron teaches:
The leadless neurostimulation device of claim 4, wherein at least one sensor of the one or more sensors is positioned along a same side of the neurostimulation device as the secondary electrode (see annotated fig. 4 below and para 0172—sensor(s) and electrode(s) discussed here).
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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 1-10, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0171313 Al to Dinsmoor et al. (hereinafter “Dinsmoor”) in view of US 2013/0079861 A1 to Reinert et al. (hereinafter “Reinert”), US 2005/0288600 Al to Zhang et al. (hereinafter “Zhang”), US 9,452,286 B2 to Cowan et al. (hereinafter “Cowan”), and US 6,869,404 B2 to Schulhauser et al. (hereinafter “Schulhauser”).
Regarding claim 1, Dinsmoor teaches a leadless neurostimulation device (para 0049) comprising a housing (para 0049, last sentence) and an array of electrode that can be arranged on the surface of the implantable stimulator in a multitude of different ways (para 0051), as well as a controller/processing circuitry configured to operate in a closed-loop (para 0173 and para 0179) to:
transmit an electrical stimulation signal between the primary electrode to the secondary electrode/more than one electrode to provide electrical stimulation therapy to a tibial nerve of a patient (para 0049 and para 0070);
measure a physiologic parameter using the one or more sensors, the primary electrode, or the secondary electrode in response to transmission of the electrical stimulation therapy (see annotated fig. 3 below, para 0006, and para 0032, lines 1-4);
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and adjust one or more parameters of the electrical stimulation signal based on the measured physiologic parameter (para 0006 and 0032).
Dinsmoor does not explicitly disclose wherein the at least one primary electrode comprises a cathode, and the secondary electrode comprising an anode.
However, Reinert teaches a device and techniques for determining an attachment stability of an implantable leadless pacing device (see abstract, lines 1-3 and fig. 2). The device (fig. 2) contains electrodes positioned on the housing of the device (see fig. 2, 34 and 36), which function as a cathode and anode for delivering pacing stimulation therapy (see para 0055 and fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Dinsmoor with the teachings of Reinert to arrive at the claimed invention. Such combination would have yield predictable results, since the application of one primary electrode comprising a cathode and the secondary electrode comprising an anode is already well known in the art for providing electrical stimulation therapy for a patient. Although Reinert teaches cathode and anode, Dinsmoor nor Reinert explicitly disclose wherein the leadless stimulation device comprises a header and footer unit, wherein the secondary electrode is positioned on the same side of the leadless neurostimulation device as the primary electrode, and, wherein one or more sensors on an exterior surface of the housing.
Yet, Zhang discloses automatic cardiac monitoring and stimulation device (see abstract, lines 1-2). The device (fig. 1) contains a header unit/arrangement (see fig. 1-189 below, fig. 6, para 0021, and para 0037, first two sentences) comprising at least one electrode containing a contact surface that defines an external surface of the stimulation device (see para 0035: “In another embodiment, one electrode may be located on the PIMD header, another is the can electrode, and a third may be a PIMD antenna used for RF telemetry.”, and para 0037, 181a). Furthermore, the device (fig. 1 and 6) discloses a can (fig. 7, 502) that can contain electrodes coupled to the housing (fig. 7, 501) either anterior or posterior of the header unit (see annotated fig. 7, para 0037, and para 0070), and a secondary electrode positioned on the housing of the implantable stimulator device (see annotated fig. 1 below), and wherein one or more sensors can be positioned on the exterior surface of the can (para 0067-emphasis on the first sentence: “The PIMD 182 may further include one or more sensors in or on the can 103, header 189, electrode module 196, or lead(s) that couple to the header 189 or electrode module 196.”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of Zhang to arrive at the claimed invention, since such modification would improve the system by providing a compact stimulation device that allows for proper separation between sensing and stimulation capabilities of the device. Although Zhang teaches the header and footer unit, they do not explicitly disclose wherein the can unit is located as a footer unit below the housing and opposite of the header unit.
Yet, Cowan discloses a system and method for an implantable leadless stimulation system (fig. 3a-3c and col. 1, lines 49-55). The device (fig. 3a-3c) contains an electrode that functions as a footer located on the bottom portion of the implantable leadless device (fig. 3c, 373 and col. 25, lines 35-43).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine and modify the modified teachings of Dinsmoor and with the teachings of Cowan to arrive at the claimed invention, since such modification and combination would yield predictable results, allowing the header and/or footer with the housing of the device to have more control over the current flow, and would therefore provide more advantageous stimulation and/or sensing capabilities of the device. Although Zhang teaches wherein the sensors are arranged on the exterior surface of the can, they do not explicitly disclose where one or more sensors located on the exterior surface of the housing are aligned linearly with the primary electrode and secondary electrode.
However, Schulhauser teaches a minimally invasive heart sound and ECG monitoring device (see abstract, lines 1-3). The device (fig. 2) contains a primary electrode, secondary electrode, and a sensor, which is aligned linearly with the primary electrode and secondary electrode (see annotated fig. 2, col. 5, lines 62-67 and col. 6, lines 1-11: “ The device 10 is provided with a hermetically sealed housing or "can" 12 preferably formed from a biocompatible metal such as titanium and closed at one end by a plastic cap member 18. Cap member 18 may be formed of materials similar to those used for pacemaker connector blocks, such as polyurethane or epoxy. Housing 12 is provided with an insulative coating 20, indicated by dashed line, formed from an insulating material, such as a Parylene coating. Device 10 is provided with at least two electrodes 14 and 16 for sensing a patient's subcutaneous ECG.”, and col. 6 , lines 19-20: “ Device 10 is further provided with a heart sound sensor 22.”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Dinsmoor and with the teachings of Schulhauser to arrive at the claimed invention, since such modification would improve the system by preventing signal interference between the sensors and stimulating electrodes in the leadless stimulation device, ultimately providing safter and more advantageous stimulation and/or sensing capabilities for the device.
Regarding claim 2, Dinsmoor as modified teaches the leadless neurostimulation device of claim 1, wherein the controller is configured to measure a physiologic parameter selected from an EMG signal, an ECAP signal, or both in response to the electrical stimulation signal (para 0032, lines 1-4 and para 0101).
Regarding claim 3, Dinsmoor as modified teaches the leadless neurostimulation device of claim 1, wherein the controller/processing circuitry (para 0173 and para 0179) is configured to measure the physiologic parameter with one or more of the primary electrode or the secondary electrode (para 0005, para 0032, and para 0049).
Regarding claim 4, Dinsmoor as modified teaches the leadless neurostimulation device of claim 1, further comprising one or more sensors positioned along an exterior surface of the housing or the footer (para 0106, lines 1-7), wherein the controller/processing circuitry is configured to measure the physiologic parameter with the one or more sensors (para 0095-para 0097).
Regarding claim 5, Dinsmoor as modified teaches the leadless neurostimulation device of claim 1, wherein the controller/processing circuitry is configured to measure the physiologic parameter with one or more sensors, the primary electrode, or the secondary electrode (para 0032, para 0087, and para 0095-0097).
Regarding claim 6, Dinsmoor as modified teaches the leadless neurostimulation device of claim 4, wherein the one or more sensors comprise a plurality of sensors (para 0095 and para 0100), wherein the controller/processing circuitry is configured to transmit the electrical stimulation signal from stimulation leads and measure the physiologic parameter/eECAP at the same time/during stimulation (para 0061, para 0071, and para 0086-0087, and para 0094).
Regarding claim 7, Dinsmoor as modified teaches the leadless neurostimulation device of claim 5, containing a plurality of sensors/microsensors (para 0095 and para 0106), of the plurality of sensors, but does not explicitly disclose wherein at least two sensors are aligned linearly with the primary electrode and the secondary electrode.
However, Schulhauser teaches a minimally invasive heart sound and ECG monitoring device (see abstract, lines 1-3). The device (fig. 2) contains a primary electrode, secondary electrode, and a sensor, which is aligned linearly with the primary electrode and secondary electrode (see annotated fig. 2, col. 5, lines 62-67 and col. 6, lines 1-11: “ The device 10 is provided with a hermetically sealed housing or "can" 12 preferably formed from a biocompatible metal such as titanium and closed at one end by a plastic cap member 18. Cap member 18 may be formed of materials similar to those used for pacemaker connector blocks, such as polyurethane or epoxy. Housing 12 is provided with an insulative coating 20, indicated by dashed line, formed from an insulating material, such as a Parylene coating. Device 10 is provided with at least two electrodes 14 and 16 for sensing a patient's subcutaneous ECG.”, and col. 6 , lines 19-20: “ Device 10 is further provided with a heart sound sensor 22.”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Dinsmoor and with the teachings of Schulhauser to arrive at the claimed invention, since such modification would improve the system by preventing signal interference between the sensors and stimulating electrodes in the leadless stimulation device, ultimately providing safter and more advantageous stimulation and/or sensing capabilities for the device.
Regarding claim 8, Dinsmoor as modified teaches the leadless neurostimulation device of claim 5, wherein the plurality of sensors comprise a plurality of electrode pairs/electrodes located on leads (para 0100 and fig. 3), each electrode pair/electrodes on leads (fig. 3, 16a and 16b) aligned substantially perpendicular along a length of the neurostimulation device.
However, in an alternative embodiment of the invention, the leads can be employed as one or more arrays of electrodes located on the housing of the device, making the electrodes parallel along the length of the neurostimulation device (para 0049 and 0051).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify one embodiment of Dinsmoor with another to arrive at the claimed invention, since employing an array of electrode aligned substantially parallel to the neurostimulation device could improve the device by enhancing its stimulation and/or tissue sensing capabilities when determining if proper stimulation has been applied to the patient’s neural tissue.
Regarding claim 9, Dinsmoor as modified teaches the leadless neurostimulation device of claim 4, but does not disclose wherein the at least one sensor of the one or more sensors is positioned along a surface of the housing, wherein the housing defines an aperture exposing the at least one sensor, the neurostimulation device further comprising a dielectric material set around the at least one sensor that electrically insulating the sensor from the housing.
However, Zhang discloses wherein at least one sensor of the one or more sensors of the stimulator is positioned along a surface of the housing (para 0070 and para 0106), and wherein the housing and can define an aperture or opening exposing the at least one sensor (para 0067 and para 0070). Furthermore, the neurostimulation device (figs. 1 and 6) further comprises a dielectric material/non-conductive material set around/near the at least one sensor (which is integrated with the can of the device) that can electrically isolate the sensor and “can” combination from the housing with a dielectric/non-conducting material (para 0070-0071).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of Zhang to arrive at the claimed invention, since the implementation of the method disclosed by Zhang would provide extra protection for the sensor and would allow assist with directing the current flow as disclosed by the prior art.
Regarding claim 10, Dinsmoor as modified teaches the leadless neurostimulation device of claim 4, but does not disclose wherein at least one sensor of the one or more sensors is positioned within the footer, wherein the footer electrically insulates the at least one sensor from the housing.
However, Zhang discloses wherein at least one sensor of the one or more sensors of the neurostimulator device (figs. 1 and 6) is positioned within the footer/can (para 0067, lines 1-3), wherein the footer/can electrically insulates the at least one sensor from the housing (para 0070-0071).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of Zhang to arrive at the claimed invention, since the implementation of the method disclosed by Zhang would provide extra protection for the sensor and would allow for proper directing of the desired current flow as disclosed by the prior art.
Regarding claim 12, Dinsmoor as modified teaches the leadless neurostimulation device of claim 4, wherein at least one sensor of the one or more sensors is positioned along a same side of the neurostimulation device as the secondary electrode/a plurality of electrodes used for neurostimulation (para 0106 and fig. 3).
Regarding claim 14, Dinsmoor as modified teaches the leadless neurostimulation device of claim 4, but does not disclose wherein the leadless neurostimulation device further comprises a dielectric/non-conductive coating that at least partially encapsulates the leadless neurostimulation device, wherein a boundary defined by the dielectric coating defines the secondary electrode.
However, Zhang discloses wherein the neurostimulation device contains a can electrode positioned on a housing of the device (para 0070). The device (figs. 1 and 6) contains portions of the housing that contain dielectric/non-conductive material coatings (para 0071 and para 0088). Furthermore, the device (figs. 1 and 6) contains a secondary multi-element electrode system defined by a dielectric/non-conductive backing (para 0068-0069).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the modified system of Dinsmoor with the teachings of Zhang to arrive at the claimed invention, since such combination would yield predictable results and due to the fact that the prior art shows that the addition of a dielectric coating is not only already known in the art, but is additionally included in order to optimally limit the current flow within the device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor, Reinert, Zhang, Cowan, Schulhauser, and further in view of US 2018/0289965 A1 to Nelson et al. (hereinafter “Nelson”).
Regarding claim 11, Dinsmoor as modified discloses a leadless neurostimulation device (para 0049) comprising a housing (para 0049, last sentence) and an array of electrode that can be arranged on the surface of the implantable stimulator in a multitude of different ways (para 0051), as well as a controller/processing circuitry configured to operate in a closed-loop (para 0173 and para 0179) to:
transmit an electrical stimulation signal between the primary electrode to the secondary electrode/more than one electrode to provide electrical stimulation therapy to a tibial nerve of a patient (para 0049 and para 0070);
measure a physiologic parameter using the one or more sensors, the primary electrode, or the secondary electrode in response to transmission of the electrical stimulation therapy (see annotated fig. 3 below, para 0006, and para 0032, lines 1-4);
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and adjust one or more parameters of the electrical stimulation signal based on the measured physiologic parameter (para 0006 and 0032).
Dinsmoor does not explicitly disclose wherein the at least one primary electrode comprises a cathode, and the secondary electrode comprising an anode.
However, Reinert teaches a device and techniques for determining an attachment stability of an implantable leadless pacing device (see abstract, lines 1-3 and fig. 2). The device (fig. 2) contains electrodes positioned on the housing of the device (see fig. 2, 34 and 36), which function as a cathode and anode for delivering pacing stimulation therapy (see para 0055 and fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the system of Dinsmoor with the teachings of Reinert to arrive at the claimed invention. Such combination would have yield predictable results, since the application of one primary electrode comprising a cathode and the secondary electrode comprising an anode is already well known in the art for providing electrical stimulation therapy for a patient. Although Reinert teaches cathode and anode, Dinsmoor nor Reinert explicitly disclose wherein the leadless stimulation device comprises a header and footer unit, wherein the secondary electrode is positioned on the same side of the leadless neurostimulation device as the primary electrode, and, wherein one or more sensors on an exterior surface of the housing.
Yet, Zhang discloses automatic cardiac monitoring and stimulation device (see abstract, lines 1-2). The device (fig. 1) contains a header unit/arrangement (see fig. 1-189 below, fig. 6, para 0021, and para 0037, first two sentences) comprising at least one electrode containing a contact surface that defines an external surface of the stimulation device (see para 0035: “In another embodiment, one electrode may be located on the PIMD header, another is the can electrode, and a third may be a PIMD antenna used for RF telemetry.”, and para 0037, 181a). Furthermore, the device (fig. 1 and 6) discloses a can (fig. 7, 502) that can contain electrodes coupled to the housing (fig. 7, 501) either anterior or posterior of the header unit (see annotated fig. 7, para 0037, and para 0070), and a secondary electrode positioned on the housing of the implantable stimulator device (see annotated fig. 1 below), and wherein one or more sensors can be positioned on the exterior surface of the can (para 0067-emphasis on the first sentence: “The PIMD 182 may further include one or more sensors in or on the can 103, header 189, electrode module 196, or lead(s) that couple to the header 189 or electrode module 196.”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of Zhang to arrive at the claimed invention, since such modification would improve the system by providing a compact stimulation device that allows for proper separation between sensing and stimulation capabilities of the device. Although Zhang teaches the header and footer unit, they do not explicitly disclose wherein the can unit is located as a footer unit below the housing and opposite of the header unit.
Yet, Cowan discloses a system and method for an implantable leadless stimulation system (fig. 3a-3c and col. 1, lines 49-55). The device (fig. 3a-3c) contains an electrode that functions as a footer located on the bottom portion of the implantable leadless device (fig. 3c, 373 and col. 25, lines 35-43).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine and modify the modified teachings of Dinsmoor and with the teachings of Cowan to arrive at the claimed invention, since such modification and combination would yield predictable results, allowing the header and/or footer with the housing of the device to have more control over the current flow, and would therefore provide more advantageous stimulation and/or sensing capabilities of the device. Although Zhang teaches wherein the sensors are arranged on the exterior surface of the can, they do not explicitly disclose where one or more sensors located on the exterior surface of the housing are aligned linearly with the primary electrode and secondary electrode.
However, Schulhauser teaches a minimally invasive heart sound and ECG monitoring device (see abstract, lines 1-3). The device (fig. 2) contains a primary electrode, secondary electrode, and a sensor, which is aligned linearly with the primary electrode and secondary electrode (see annotated fig. 2, col. 5, lines 62-67 and col. 6, lines 1-11: “ The device 10 is provided with a hermetically sealed housing or "can" 12 preferably formed from a biocompatible metal such as titanium and closed at one end by a plastic cap member 18. Cap member 18 may be formed of materials similar to those used for pacemaker connector blocks, such as polyurethane or epoxy. Housing 12 is provided with an insulative coating 20, indicated by dashed line, formed from an insulating material, such as a Parylene coating. Device 10 is provided with at least two electrodes 14 and 16 for sensing a patient's subcutaneous ECG.”, and col. 6 , lines 19-20: “ Device 10 is further provided with a heart sound sensor 22.”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified teachings of Dinsmoor and with the teachings of Schulhauser to arrive at the claimed invention, since such modification would improve the system by preventing signal interference between the sensors and stimulating electrodes in the leadless stimulation device, ultimately providing safter and more advantageous stimulation and/or sensing capabilities for the device.
Lastly, Dinsmoor does not disclose wherein at least one sensor of the one or more sensors is positioned along a perimeter edge of the neurostimulation device.
However, Nelson teaches a neurostimulation device that contains a sensor located along the perimeter edge of the neurostimulation device (see abstract and annotated fig. 2 below).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of Nelson to arrive at the claimed invention, since such modification would improve the system by allowing the sensor(s) to be in closer proximity to stimulation nerve site, allowing for the sensors to more accurately pick up the stimulation response and allowing for faster adjustment of stimulation parameters if needed.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor, Reinert, Zhang, Cowan, Schulhauser, and further in view of US 2016/0339239 A1 to Yoo et al. (hereinafter “Yoo”) and US 2020/0206511 A1 to Goedeke et al. (hereinafter “Goedeke”).
Regarding claim 13, Dinsmoor as modified teaches the leadless neurostimulation device of claim 4 containing both sensors and a primary electrode located on the housing of the device (fig. 3, 0051, and para 0106), but does not disclose wherein each of the one or more sensors are separated from the primary electrode/electrodes by an edge-to-edge separation distance of at least about 3 mm.
However, Yoo discloses systems and methods for providing neurostimulation therapy to various nerves, including the posterior tibial nerve (PTN) and the Saphenous nerve (SAFN) (abstract, lines 1-5). The system (fig. 19) contains a first, second, and third implantable stimulators (containing a first and second electrode used to stimulate both a PTN and SAFN nerve and serving as the cathode, while the third stimulator serves as the anode or vice versa) (para 0386). The stimulators (specifically the first stimulator (652) and second stimulator (654) shown in fig. 50e) were set 3mm to 5mm apart to provide independent and optimal stimulation to the nerves (para 0386). Yoo does not disclose wherein the sensors and electrodes are at least 3 mm apart.
However, Goedeke discloses a method and system for cardiac electrical neurostimulation (para 0002). The system (fig. 1) contains both sensors and electrodes that are approximately a distance between 1cm-5cm (para 0754, lines 1-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of Yoo and Goedeke to arrive at the claimed invention, since such modification would improve the system by reducing the interference between the sensors and electrodes, ensuring that the sensors receive proper signals needed for adjusting the stimulation parameters and signal during therapeutic treatment.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Oron in view of US 2016/0339239 A1 to Yoo et al. (hereinafter “Yoo”) and US 2020/0206511 A1 to Goedeke et al. (hereinafter “Goedeke”).
Regarding claim 13, Oron teaches the leadless neurostimulation device/electrostimulator implant of claim 4, but does not disclose wherein each of the one or more sensors are separated from the primary electrode/electrodes by an edge-to-edge separation distance of at least about 3 mm.
However, Yoo discloses systems and methods for providing neurostimulation therapy to various nerves, including the posterior tibial nerve (PTN) and the Saphenous nerve (SAFN) (abstract, lines 1-5). The system (fig. 19) contains a first, second, and third implantable stimulators (containing a first and second electrode used to stimulate both a PTN and SAFN nerve and serving as the cathode, while the third stimulator serves as the anode or vice versa) (para 0386). The stimulators (specifically the first stimulator (652) and second stimulator (654) shown in fig. 50e) were set 3mm to 5mm apart to provide independent and optimal stimulation to the nerves (para 0386). Yoo does not disclose wherein the sensors and electrodes are at least 3 mm apart.
However, Goedeke discloses a method and system for cardiac electrical neurostimulation (para 0002). The system (fig. 1) contains both sensors and electrodes that are approximately a distance between 1cm-5cm (para 0754, lines 1-8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Oron with the teachings of Yoo and Goedeke to arrive at the claimed invention, since such modification would improve the system by reducing the interference between the sensors and electrodes, ensuring that the sensors receive proper signals needed for adjusting the stimulation parameters and signal during therapeutic treatment.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor, Reinert, Zhang, Cowan, and Schulhauser, and further in view of US 2020/0254263 A1 to Deininger et al. (hereinafter “Deininger”).
Regarding claim 15, Dinsmoor as modified teaches the leadless neurostimulation device of claim 1, but does not disclose wherein the leadless neurostimulation device further comprises a mounting plate, wherein the housing is coupled to a first side of the mounting plate and the header unit is coupled to a second side of the mounting plate.
However, Zhang discloses wherein the implantable neurostimulator device contains a coupler (fig. 6, 193), a header unit (fig. 6, 189), and can/housing combination (figs. 1, 6-103, fig. 7-501 & 502, and para 0070). When the coupler is attached to the header unit, the can and housing combination is located on one side of the coupler, while the header unit is located on the other side of the coupler (see annotated fig. 6 below). Zhang does not disclose wherein the coupler is a mount or mounting plate.
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Nevertheless, Deininger discloses an implantable medical neurostimulator (abstract and fig. 1). The device (fig. 1) contains a mount connecting the header body/unit to one side of the device (fig. 1, 112) and a primary device housing connected to the other side of the mount (fig. 1, 110 and para 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of both Zhang and Deininger to arrive at the claimed invention, since such modification would improve the system by allowing the for the addition of a single electrode/sensor head or multiple electrodes/sensors head when detecting the stimulation response or administering stimulation through more than one electrode.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Oron in view of US 2020/0254263 A1 to Deininger et al. (hereinafter “Deininger”).
Regarding claim 15, Oron teaches the leadless neurostimulation device/electrostimulator implant of claim 1, but does not disclose wherein the leadless neurostimulation device further comprises a mounting plate, wherein the housing is coupled to a first side of the mounting plate and the header unit is coupled to a second side of the mounting plate.
However, Zhang discloses wherein the implantable neurostimulator device contains a coupler (fig. 6, 193), a header unit (fig. 6, 189), and can/housing combination (figs. 1, 6-103, fig. 7-501 & 502, and para 0070). When the coupler is attached to the header unit, the can and housing combination is located on one side of the coupler, while the header unit is located on the other side of the coupler (see annotated fig. 6 below). Zhang does not disclose wherein the coupler is a mount or mounting plate.
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Nevertheless, Deininger discloses an implantable medical neurostimulator (abstract and fig. 1). The device (fig. 1) contains a mount connecting the header body/unit to one side of the device (fig. 1, 112) and a primary device housing connected to the other side of the mount (fig. 1, 110 and para 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Oron with the teachings of both Zhang and Deininger to arrive at the claimed invention, since such modification would improve the system by allowing the for the addition of a single electrode/sensor head or multiple electrodes/sensors head when detecting the stimulation response or administering stimulation through more than one electrode.
Claims 16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor, Reinert, Zhang, Cowan, Schulhauser, and further in view of US 2015/0012071 A1 to Bradley et al. (hereinafter “Bradley”).
Regarding claim 16, Dinsmoor teaches the leadless neurostimulation device of claim 1, but does not disclose wherein the device defines a total volume of about 1.5 cubic centimeters (cc) to about 3.5 cc.
However, Bradley discloses an implantable neurostimulator pulse generator device system (abstract and fig. 2, 30 and fig. 4, 200). The device (fig. 2, 30 and fig. 4, 200) has a total volume of less than 5 cubic centimeters (figs. 4-5, and para 0045).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of Bradley to arrive at the claimed invention, since to one can engage in routine experimentation to discover the optimal total volume range of 1.5 cc to 3.5 cc in order to ensure the device is the optimal size for the patient while still performing optimal neurostimulation. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 18, Dinsmoor as modified teaches the neurostimulation device of claim 16, wherein the controller/processing circuitry is configured to transmit the electrical stimulation signal from stimulation leads and measure the physiologic parameter/eECAP at the same time/during stimulation (para 0061, para 0071, para 0087 and para 0094).
Regarding claim 19, Dinsmoor as modified discloses the neurostimulation device of claim 16, but does not disclose wherein the header unit and the housing combined define a total volume of about 1.5 cubic centimeters to about 3.5 cubic centimeters.
However, Bradley discloses an implantable neurostimulator pulse generator device system (abstract and fig. 2, 30 and fig. 4, 200). The device (fig. 2, 30 and fig. 4, 200) comprising of an epoxy header and an enclosure/housing has a total volume of less than 5 cubic centimeters (see annotated fig. 4, fig. 5, and para 0045).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Dinsmoor with the teachings of Bradley to arrive at the claimed invention, since to one can engage in routine experimentation to discover the optimal total volume range of 1.5 cc to 3.5cc for the header and housing combined in order to ensure the device is the optimal size for the patient while still performing optimal neurostimulation. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Oron in view of US 2015/0012071 A1 to Bradley et al. (hereinafter “Bradley”).
Regarding claim 16, Oron teaches the leadless neurostimulation device of claim 1, but does not disclose wherein the device defines a total volume of about 1.5 cubic centimeters (cc) to about 3.5 cc.
However, Bradley discloses an implantable neurostimulator pulse generator device system (abstract and fig. 2, 30 and fig. 4, 200). The device (fig. 2, 30 and fig. 4, 200) has a total volume of less than 5 cubic centimeters (figs. 4-5, and para 0045).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Oron with the teachings of Bradley to arrive at the claimed invention, since to one can engage in routine experimentation to discover the optimal total volume range of 1.5 cc to 3.5 cc in order to ensure the device is the optimal size for the patient while still performing optimal neurostimulation. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 19, Oron as modified discloses the neurostimulation device of claim 16, but does not disclose wherein the header unit and the housing combined define a total volume of about 1.5 cubic centimeters to about 3.5 cubic centimeters.
However, Bradley discloses an implantable neurostimulator pulse generator device system (abstract and fig. 2, 30 and fig. 4, 200). The device (fig. 2, 30 and fig. 4, 200) comprising of an epoxy header and an enclosure/housing has a total volume of less than 5 cubic centimeters (see annotated fig. 4, fig. 5, and para 0045).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system of Oron with the teachings of Bradley to arrive at the claimed invention, since to one can engage in routine experimentation to discover the optimal total volume range of 1.5 cc to 3.5cc for the header and housing combined in order to ensure the device is the optimal size for the patient while still performing optimal neurostimulation. See MPEP § 2144.05(II)(A) (“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Carmena et al. (US 2021/0308462 A1) discloses an implantable closed-loop neurostimulation system and device.
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/K.J.W./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792