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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05 Nov 2025 has been entered.
This Office Action is responsive to the amendment filed on 05 Nov 2025. As directed by the amendment: claims 1 and 14 have been amended, claims 16-17, 21, and 23-50 have been canceled, and no claims have been added. Thus, claims 1-15, 18-20, and 22 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05 Nov 2025, with respect to the rejection(s) of claim(s) 1 and 14 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Karr et al. (US 20140207252 A1), hereinafter Karr, as explained in detail 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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karr et al. (US 20140207252 A1), hereinafter Karr.
Regarding claim 1, Karr discloses a system comprising:
a sensor (Fig. 1, paragraph [0028], sensor 121), wherein the sensor is configured for subcutaneous and/or subdermal placement (paragraph [0028], "A person may have lost or impaired ability to sense touch in a particular region of the body such as a hand 110. One or more bionic implants 120 are placed in locations where sensor information is desirable") and wherein the sensor is configured to detect a pressure (paragraphs [0024], [0039], [0043]);
a stimulator, wherein the stimulator is configured for subcutaneous placement (paragraph [0024], "BION microstimulator that is implanted in a patient") to electrically stimulate at least one nerve (paragraph [0025], "the sensory device is configured in communication with a set of electrodes that are implanted in a neural pathway"); and
a controller, wherein the controller is operably coupled to the sensor and the stimulator (Fig. 1, paragraph [0029], MCU 130), and wherein the controller is configured to:
operate the sensor to detect a pressure of skin at the location of the sensor (paragraph [0024], "the impedance observed by the sensor changes when: the skin tissue is deformed around the sensor"; paragraph [0039], "At the skin boundary, some RF signals are transmitted out of the tissue while others are reflected back towards the tissue. The reflectivity of the tissue at the boundary is dependent on the complex impedances of the tissue(s) and of the external environment. For example, the complex RF impedance of the surrounding tissue changes when the shape of the tissue immediately surrounding the bionic implant device changes due to external pressure."); and
based on the detected pressure at the location of the sensor, operate the stimulator to provide a stimulus to the at least one nerve to evoke a perception of at least one of touch, pressure, or deformation at the skin at the location of the sensor based on the detected pressure of skin at the sensor (paragraph [0024], "the impedance observed by the sensor changes when: the skin tissue is deformed around the sensor, or when the skin is surrounded by water. The sensory information is interpreted by the brain as an analog of touch or feel."; paragraph [0028], "Sensor circuit 121 provides sensory information to communication circuit 122, which subsequently communicates information to the brain. The brain receives the sensory information and interprets the sensory information as touch or feel."; paragraph [0029], "Sensor processing circuit 131 is arranged to communicate to the MCU, where the sensory information may be further processed for application. ... The sensory information is interpreted as touch or feel.").
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 2 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Pivonka et al. (WO 2017044904 A1, previously cited), hereinafter Pivonka.
Regarding claim 2, Karr discloses the system of claim 1, as explained above. Karr does not explicitly disclose that the sensor is configured to be surgically secured to an internal surface of skin.
However, Pivonka teaches a sensor, wherein the sensor is configured for subcutaneous and/or subdermal placement (Fig. 1, paragraph [0268], one or more sensor-based functional elements 260 positioned in subcutaneous tissue), and wherein the sensor is configured to be surgically secured to an internal surface of skin (paragraph [0268], "one or more implantable devices 200 are positioned in subcutaneous tissue"; paragraph [0319]).
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 Karr with the teachings of Pivonka so that the sensor is configured to be surgically secured to an internal surface of skin, because doing so prevents migration of the sensor (Pivonka, paragraph [0519]).
Regarding claim 6, Karr discloses the system of claim 1, as explained above. Although Karr further discloses that the stimulator is electrically coupled to a nerve via one or more electrodes (paragraphs [0023], [0030], [0044]), Karr does not explicitly disclose that the stimulator comprises: a first housing configured to be mechanically coupled to a first nerve; and a first electrode coupled to the first housing such that, when the first housing is coupled to the nerve, an electrical stimulus can be provided to the first nerve via the first electrode.
However, Pivonka teaches a stimulator (Fig. 1, paragraph [0266], “one or more functional elements 260 are configured to deliver energy (e.g. electrical energy) to tissue to treat heart failure, such as tissue selected from the group consisting of: spinal canal; nerves in the spinal canal; nerves in the epidural space; peripheral nerves; posterior spinal nerve root; dorsal root; dorsal root ganglion; pre-ganglionic tissue on posterior spinal nerve root; post-ganglionic tissue on posterior nerve root; dorsal ramus; grey ramus communicans; white ramus communicans; ventral ramus; and combinations of one or more of these”), wherein the stimulator comprises:
a first housing configured to be mechanically coupled to a first nerve (Fig. 1, paragraph [0310], "Each implantable device 200 can comprise one or more leads 265, such as two leads attached to a single housing 210, or a first lead 265 attached to a first housing 210 and a second lead 265 attached to a second housing 265"; paragraph [0310], "One or more functional elements 260 can be positioned on a lead 265, such as is described herebelow in reference to Fig. 2"; paragraph [0381], "implantable apparatus 10 comprises one or more functional elements 260 comprising a magnetic field generating transducer (e.g. microcoils or cuff electrodes positioned to partially surround or otherwise be proximate to one or more target nerves)"; paragraph [0391], "Leads 265 can comprise one or more functional elements 260 comprising cylindrical, paddle, cuff and/or hemi-cuff electrodes (electrodes placed surgically near and/or around these nerves)"); and
a first electrode coupled to the first housing such that, when the first housing is coupled to the nerve, an electrical stimulus can be provided to the first nerve via the first electrode (paragraphs [0266], [0334]-[0335], [0347], [0356], [0358]).
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 Karr with the teachings of Pivonka so that the stimulator comprises a first housing configured to be mechanically coupled to a first nerve; and a first electrode coupled to the first housing such that, when the first housing is coupled to the nerve, an electrical stimulus can be provided to the first nerve via the first electrode, because doing so minimizes effects on non-targeted tissue (Pivonka, paragraph [0381]).
Regarding claim 7, the system of claim 6 is obvious over Karr and Pivonka, as explained above. Karr does not explicitly disclose that the stimulator comprises: a first housing configured to be mechanically coupled to a first nerve; and a first electrode coupled to the first housing such that, when the first housing is coupled to the nerve, an electrical stimulus can be provided to the first nerve via the first electrode.
However, Pivonka teaches a stimulator (Fig. 1, paragraph [0266], “one or more functional elements 260 are configured to deliver energy (e.g. electrical energy) to tissue to treat heart failure, such as tissue selected from the group consisting of: spinal canal; nerves in the spinal canal; nerves in the epidural space; peripheral nerves; posterior spinal nerve root; dorsal root; dorsal root ganglion; pre-ganglionic tissue on posterior spinal nerve root; post-ganglionic tissue on posterior nerve root; dorsal ramus; grey ramus communicans; white ramus communicans; ventral ramus; and combinations of one or more of these”), wherein the stimulator comprises:
a second housing configured to be mechanically coupled to a second nerve (Fig. 2, paragraph [0260]; paragraph [0310], "Each implantable device 200 can comprise one or more leads 265, such as two leads attached to a single housing 210, or a first lead 265 attached to a first housing 210 and a second lead 265 attached to a second housing 265"; paragraph [0310], "One or more functional elements 260 can be positioned on a lead 265, such as is described herebelow in reference to Fig. 2"; paragraph [0381], "implantable apparatus 10 comprises one or more functional elements 260 comprising a magnetic field generating transducer (e.g. microcoils or cuff electrodes positioned to partially surround or otherwise be proximate to one or more target nerves)"; paragraph [0391], "Leads 265 can comprise one or more functional elements 260 comprising cylindrical, paddle, cuff and/or hemi-cuff electrodes (electrodes placed surgically near and/or around these nerves)"); and
a second electrode coupled to the second housing such that, when the second housing is coupled to the second nerve, an electrical stimulus can be provided to the second nerve via the second electrode (paragraphs [0266], [0334]-[0335], [0347], [0356], [0358]).
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 Karr with the teachings of Pivonka so that the stimulator comprises a second housing configured to be mechanically coupled to a second nerve; and a second electrode coupled to the second housing such that, when the second housing is coupled to the second nerve, an electrical stimulus can be provided to the second nerve via the second electrode, because doing so minimizes effects on non-targeted tissue (Pivonka, paragraph [0381]).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Denk (DE 102010033356 A1).
Regarding claim 3, Karr discloses the system of claim 1, as explained above. Karr does not explicitly disclose that the sensor is a flexible sensor.
However, Denk teaches a breast prosthesis (Abstract) comprising a flexible sensor (page 3 of English translation, "Since a breast naturally is very flexible, sometimes quite 'kneaded' during sex, a suitable sensor must withstand all these influences without being tactile").
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 Karr with the teachings of Denk so that the sensor is a flexible sensor, because doing so allows the implant to feel more natural (Denk, page 2 of English translation, "a touch of the artificial breast should as much as possible resemble the feeling as if a natural breast were being touched").
Regarding claim 4, the system of claim 3 is obvious over Karr and Denk, as explained above. Neither Karr nor Denk explicitly discloses that the flexible sensor has a compliance that is within 30% of a compliance of human breast tissue. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a flexible sensor with a compliance that is within 30% of a compliance of human breast tissue, for the purpose of improving comfort and sensitivity, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 5, the system of claim 3 is obvious over Karr and Denk, as explained above. Neither Karr nor Denk explicitly discloses that the flexible sensor has a compliance that is within 30% of a compliance of human skin tissue. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a flexible sensor with a compliance that is within 30% of a compliance of human skin tissue, for the purpose of improving comfort and sensitivity, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Pivonka et al. (WO 2017044904 A1, previously cited), hereinafter Pivonka, and further in view of Ward et al. (US 20160346164 A1, previously cited), hereinafter Ward.
Regarding claim 8, the system of claim 7 is obvious over Karr and Pivonka, as explained above. Neither Karr nor Pivonka explicitly discloses that operating the sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises: (i) during a first period of time, detecting a first sensor signal from a first region of the flexible sensor, and (ii) during a second period of time, detecting a second sensor signal from a second region of the flexible sensor, wherein the second region differs from the first region, wherein operating the stimulator to provide a stimulus to the at least one nerve comprises: (i) during the first period of time, providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal, and (ii) during the second period of time, providing, to the second nerve via the second electrode, a second stimulus based on the second sensor signal, and wherein the second nerve differs from the first nerve.
However, Ward teaches a feedback system for a prosthesis (Abstract), wherein operating a sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises:
(i) during a first period of time, detecting a first sensor signal from a first region of the flexible sensor (paragraph [0066], "sensor 102 detects pressure corresponding to a handshake"), and
(ii) during a second period of time, detecting a second sensor signal from a second region of the flexible sensor (paragraph [0067]),
wherein operating the stimulator to provide a stimulus to the at least one nerve comprises:
(i) during the first period of time, providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal (paragraph [0066], "provide corresponding stimulation to the nerves 106 via the actuators 104"), and
(ii) during the second period of time, providing, to the second nerve via the second electrode, a second stimulus based on the second sensor signal (paragraph [0066], "provide corresponding stimulation to the nerves 106 via the actuators 104"; paragraphs [0062], [0067], [0134] disclose the use of more than one actuator), and
wherein the second nerve differs from the first nerve (paragraph [0057]).
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 Karr and Pivonka with the teachings of Ward to so that operating the sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises, during a first period of time, detecting a first sensor signal from a first region of the flexible sensor, and wherein operating the stimulator to provide a stimulus to the at least one nerve comprises, during the first period of time: (i) providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal, and (ii) providing, to the second nerve via the second electrode, a second stimulus based on the first sensor signal, wherein the second nerve differs from the first nerve, because doing so can restore sensation in a way that feels natural to the user (Ward, paragraph [0059]).
Ward does not explicitly disclose that the second region differs from the first region. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use different sensors in different regions, for the purpose of localizing detection of stimuli, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 9, the system of claim 7 is obvious over Karr and Pivonka, as explained above. Neither Karr nor Pivonka explicitly discloses that operating the sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises, during a first period of time, detecting a first sensor signal from a first region of the sensor, and wherein operating the stimulator to provide a stimulus to the at least one nerve comprises, during the first period of time: (i) providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal, and (ii) providing, to the second nerve via the second electrode, a second stimulus based on the first sensor signal, wherein the second nerve differs from the first nerve.
However, Ward teaches a feedback system for a prosthesis (Abstract), wherein operating a sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises: during a first period of time, detecting a first sensor signal from a first region of the flexible sensor (paragraph [0066], "sensor 102 detects pressure corresponding to a handshake"), and
wherein operating the stimulator to provide a stimulus to the at least one nerve comprises, during the first period of time:
providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal (paragraph [0066], "provide corresponding stimulation to the nerves 106 via the actuators 104"), and
providing, to the second nerve via the second electrode, a second stimulus based on the first sensor signal (paragraph [0066], "provide corresponding stimulation to the nerves 106 via the actuators 104"; paragraphs [0062], [0067], [0134] disclose the use of more than one actuator),
wherein the second nerve differs from the first nerve (paragraph [0057]).
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 Karr and Pivonka with the teachings of Ward to so that operating the sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises, during a first period of time, detecting a first sensor signal from a first region of the flexible sensor, and wherein operating the stimulator to provide a stimulus to the at least one nerve comprises, during the first period of time: (i) providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal, and (ii) providing, to the second nerve via the second electrode, a second stimulus based on the first sensor signal, wherein the second nerve differs from the first nerve, because doing so can restore sensation in a way that feels natural to the user (Ward, paragraph [0059]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Denk (DE 102010033356 A1), and further in view of Miller et al. (US 20040064133 A1, previously cited), hereinafter Miller.
Regarding claim 10, the system of claim 3 is obvious over Karr and Denk, as explained above. Neither Karr nor Denk explicitly discloses that the flexible sensor has a plurality of apertures to permit through-growth of tissue.
However, Miller teaches a system for non-vascular sensor implantation (Abstract) comprising a sensor with a plurality of apertures to permit through-growth of tissue (Fig. 14, paragraph [0089]).
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 Karr and Denk with the teachings of Miller so that the flexible sensor has a plurality of apertures to permit through-growth of tissue, because doing so provides structural stability for the sensor (Miller, paragraphs [0007], [0089]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Denk (DE 102010033356 A1), and further in view of Rowland et al. (US 20160324443 A1), hereinafter Rowland.
Regarding claim 11, the system of claim 3 is obvious over Karr and Denk, as explained above. Neither Karr nor Denk explicitly discloses that the flexible sensor comprises a plurality of flexible capacitive sensor elements.
However, Rowland teaches an implantable flexible capacitive pressure sensor (paragraphs [0051], [0062]), and an implantable capacitive temperature sensor (paragraph [0068]).
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 Karr and Denk with the teachings of Rowland so that the flexible sensor comprises a plurality of flexible capacitive sensor elements because doing so reduces the overall size of the implant (Rowland, paragraph [0061]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Ward et al. (US 20160346164 A1, previously cited), hereinafter Ward.
Regarding claim 12, Karr discloses the system of claim 1, as explained above. Karr does not explicitly disclose that the controller is additionally configured to: operate in a first mode, wherein operating in the first mode comprises: operating the sensor to detect a first at least one of a pressure, a strain, a temperature, or a vibration; determining, based on the detected first at least one of a pressure, a strain, a temperature, or a vibration, a first stimulus waveform according to a first mapping; and operating the stimulator to provide the determined first stimulus waveform; receive a mode change instruction; and responsive to receiving the mode change instruction, operate in a second mode, wherein operating in the second mode comprises: operating the sensor to detect a second at least one of a pressure, a strain, a temperature, or a vibration; operating the sensor to detect a second at least one of a pressure, a strain, a temperature, or a vibration; determining, based on the detected second at least one of a pressure, a strain, a temperature, or a vibration, a second stimulus waveform according to a second mapping, wherein the second mapping differs from the first mapping; and operating the stimulator to provide the determined second stimulus waveform.
However, Ward teaches a feedback system for a prosthesis (Abstract) comprising a controller (Fig. 1, paragraph [0062], processor 108) configured to:
operate in a first mode, wherein operating in the first mode comprises:
operating the sensor to detect a first at least one of a pressure, a strain, a temperature, or a vibration (paragraph [0075], "the training process includes monitoring sensor 102 and neural sensor 110 outputs while the user performs actions such as everyday tasks");
determining, based on the detected first at least one of a pressure, a strain, a temperature, or a vibration, a first stimulus waveform according to a first mapping (paragraphs [0073]-[0074]); and
operating the stimulator to provide the determined first stimulus waveform (paragraph [0066]).
Ward further teaches that the process is repeated for several actuators (paragraphs [0062], [0067], [0134]).
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 Karr with the teachings of Ward to operate in a first mode, wherein operating in the first mode comprises: operating the sensor to detect a first at least one of a pressure, a strain, a temperature, or a vibration; determining, based on the detected first at least one of a pressure, a strain, a temperature, or a vibration, a first stimulus waveform according to a first mapping; and operating the stimulator to provide the determined first stimulus waveform; receive a mode change instruction; and responsive to receiving the mode change instruction, operate in a second mode, wherein operating in the second mode comprises: operating the sensor to detect a second at least one of a pressure, a strain, a temperature, or a vibration; operating the sensor to detect a second at least one of a pressure, a strain, a temperature, or a vibration; determining, based on the detected second at least one of a pressure, a strain, a temperature, or a vibration, a second stimulus waveform according to a second mapping, wherein the second mapping differs from the first mapping; and operating the stimulator to provide the determined second stimulus waveform, because doing so can restore sensation in a way that feels natural to the user (Ward, paragraph [0059]).
Regarding claim 13, the system of claim 12 is obvious over Karr and Ward, as explained above. Ward further teaches that receiving a mode change instruction comprises operating a wireless receiver to detect a wireless indication of the mode change instruction (paragraphs [0091]-[0092], [0094]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Hunter (US 20170181825 A1, previously cited).
Regarding claim 14, Karr discloses a system comprising:
a sensor (Fig. 1, paragraph [0028], sensor 121), wherein the sensor is configured for subcutaneous and/or subdermal placement (paragraph [0028], "A person may have lost or impaired ability to sense touch in a particular region of the body such as a hand 110. One or more bionic implants 120 are placed in locations where sensor information is desirable") and wherein the sensor is configured to detect a pressure (paragraphs [0024], [0039], [0043]);
a stimulator, wherein the stimulator is configured for subcutaneous placement (paragraph [0024], "BION microstimulator that is implanted in a patient") to electrically stimulate at least one nerve (paragraph [0025], "the sensory device is configured in communication with a set of electrodes that are implanted in a neural pathway"); and
a controller, wherein the controller is operably coupled to the sensor and the stimulator (Fig. 1, paragraph [0029], MCU 130), and wherein the controller is configured to:
operate the sensor to detect a pressure of skin at the location of the sensor (paragraph [0024], "the impedance observed by the sensor changes when: the skin tissue is deformed around the sensor"; paragraph [0039], "At the skin boundary, some RF signals are transmitted out of the tissue while others are reflected back towards the tissue. The reflectivity of the tissue at the boundary is dependent on the complex impedances of the tissue(s) and of the external environment. For example, the complex RF impedance of the surrounding tissue changes when the shape of the tissue immediately surrounding the bionic implant device changes due to external pressure."); and
based on the detected pressure at the location of the sensor, operate the stimulator to provide a stimulus to the at least one nerve to evoke a perception of at least one of touch, pressure, or deformation at the skin at the location of the sensor based on the detected pressure of skin at the sensor (paragraph [0024], "the impedance observed by the sensor changes when: the skin tissue is deformed around the sensor, or when the skin is surrounded by water. The sensory information is interpreted by the brain as an analog of touch or feel."; paragraph [0028], "Sensor circuit 121 provides sensory information to communication circuit 122, which subsequently communicates information to the brain. The brain receives the sensory information and interprets the sensory information as touch or feel."; paragraph [0029], "Sensor processing circuit 131 is arranged to communicate to the MCU, where the sensory information may be further processed for application. ... The sensory information is interpreted as touch or feel.").
Karr does not explicitly disclose a breast implant, wherein the breast implant is configured for subcutaneous placement, wherein the sensor is disposed on or within the breast implant proximate to a surface of the breast implant such that, when the breast implant is placed subcutaneously in a patient, the sensor can detect at least one of a pressure, a strain, a vibration, or a temperature of skin overlaying the breast implant at the location of the sensor.
However, Hunter teaches a breast implant (paragraph [0029]), wherein the breast implant is configured for subcutaneous placement (paragraph [0032]), and a sensor (Fig. 3, paragraph [0040]), wherein the sensor is disposed on or within the breast implant proximate to a surface of the breast implant (paragraph [0040], "one or more position sensors are placed…on or within the 'shell' of an implant"), and wherein the sensor detects at least one of a pressure (paragraph [0035], contact sensor or fluid/pressure sensors), a strain (paragraph [0065], strain gauge; paragraph [0035], mechanical stress sensor), or a temperature (paragraph [0035], temperature sensor).
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 Karr with the teachings of Hunter to include a breast implant, wherein the breast implant is configured for subcutaneous placement, wherein the sensor is disposed on or within the breast implant proximate to a surface of the breast implant such that, when the breast implant is placed subcutaneously in a patient, the sensor can detect at least one of a pressure, a strain, a vibration, or a temperature of skin overlaying the breast implant at the location of the sensor, because doing so enables monitoring of the condition of the breast implant and its interactions with the patient's own body tissues during and after the patient's recovery from the implant surgery (Hunter, paragraphs [0009], [0028], [0061]-[0065], [0071]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Hunter (US 20170181825 A1, previously cited), and further in view of Linares (US 20120143330 A1).
Regarding claim 15, the system of claim 14 is obvious over Karr and Hunter, as explained above. Neither Karr nor Hunter explicitly discloses that the surface of the breast implant is configured to be surgically secured to an internal surface of skin.
However, Linares teaches a breast implant (Abstract) that is configured to be surgically secured to an internal surface of skin (paragraph [0057]).
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 Karr and Hunter with the teachings of Linares so that the surface of the breast implant is configured to be surgically secured to an internal surface of skin, because doing so allows a surgeon to secure and position the implant in a manner which maintains is orientation (angle) and prevents migration (movement) of the implant (Linares, paragraph [0058]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Hunter (US 20170181825 A1, previously cited), and further in view of Pivonka et al. (WO 2017044904 A1, previously cited), hereinafter Pivonka.
Regarding claim 18, the system of claim 14 is obvious over Karr and Hunter, as explained above. Karr does not explicitly disclose that the stimulator comprises: a first housing configured to be mechanically coupled to a first nerve; and a first electrode coupled to the first housing such that, when the first housing is coupled to the nerve, an electrical stimulus can be provided to the first nerve via the first electrode; a second housing configured to be mechanically coupled to a second nerve; and a second electrode coupled to the second housing such that, when the second housing is coupled to the second nerve, an electrical stimulus can be provided to the second nerve via the second electrode.
However, Pivonka teaches a stimulator (Fig. 1, paragraph [0266], “one or more functional elements 260 are configured to deliver energy (e.g. electrical energy) to tissue to treat heart failure, such as tissue selected from the group consisting of: spinal canal; nerves in the spinal canal; nerves in the epidural space; peripheral nerves; posterior spinal nerve root; dorsal root; dorsal root ganglion; pre-ganglionic tissue on posterior spinal nerve root; post-ganglionic tissue on posterior nerve root; dorsal ramus; grey ramus communicans; white ramus communicans; ventral ramus; and combinations of one or more of these”), wherein the stimulator comprises:
a first housing configured to be mechanically coupled to a first nerve (Fig. 1, paragraph [0310], "Each implantable device 200 can comprise one or more leads 265, such as two leads attached to a single housing 210, or a first lead 265 attached to a first housing 210 and a second lead 265 attached to a second housing 265"; paragraph [0310], "One or more functional elements 260 can be positioned on a lead 265, such as is described herebelow in reference to Fig. 2"; paragraph [0381], "implantable apparatus 10 comprises one or more functional elements 260 comprising a magnetic field generating transducer (e.g. microcoils or cuff electrodes positioned to partially surround or otherwise be proximate to one or more target nerves)"; paragraph [0391], "Leads 265 can comprise one or more functional elements 260 comprising cylindrical, paddle, cuff and/or hemi-cuff electrodes (electrodes placed surgically near and/or around these nerves)"); and
a first electrode coupled to the first housing such that, when the first housing is coupled to the nerve, an electrical stimulus can be provided to the first nerve via the first electrode (paragraphs [0266], [0334]-[0335], [0347], [0356], [0358]);
a second housing configured to be mechanically coupled to a second nerve (Fig. 2, paragraph [0260]; paragraph [0310], "Each implantable device 200 can comprise one or more leads 265, such as two leads attached to a single housing 210, or a first lead 265 attached to a first housing 210 and a second lead 265 attached to a second housing 265"; paragraph [0310], "One or more functional elements 260 can be positioned on a lead 265, such as is described herebelow in reference to Fig. 2"; paragraph [0381], "implantable apparatus 10 comprises one or more functional elements 260 comprising a magnetic field generating transducer (e.g. microcoils or cuff electrodes positioned to partially surround or otherwise be proximate to one or more target nerves)"; paragraph [0391], "Leads 265 can comprise one or more functional elements 260 comprising cylindrical, paddle, cuff and/or hemi-cuff electrodes (electrodes placed surgically near and/or around these nerves)"); and
a second electrode coupled to the second housing such that, when the second housing is coupled to the second nerve, an electrical stimulus can be provided to the second nerve via the second electrode (paragraphs [0266], [0334]-[0335], [0347], [0356], [0358]).
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 Karr and Hunter with the teachings of Pivonka so that the stimulator comprises: a first housing configured to be mechanically coupled to a first nerve; and a first electrode coupled to the first housing such that, when the first housing is coupled to the nerve, an electrical stimulus can be provided to the first nerve via the first electrode; a second housing configured to be mechanically coupled to a second nerve; and a second electrode coupled to the second housing such that, when the second housing is coupled to the second nerve, an electrical stimulus can be provided to the second nerve via the second electrode, because doing so minimizes effects on non-targeted tissue (Pivonka, paragraph [0381]).
Claims 19-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Karr et al. (US 20140207252 A1), hereinafter Karr, in view of Hunter (US 20170181825 A1, previously cited), and in view of Pivonka et al. (WO 2017044904 A1, previously cited), hereinafter Pivonka, and further in view of Ward et al. (US 20160346164 A1, previously cited), hereinafter Ward.
Regarding claim 19, the system of claim 18 is obvious over Karr and Pivonka, as explained above. Neither Karr nor Pivonka explicitly discloses that operating the sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises: (i) during a first period of time, detecting a first sensor signal from a first region of the flexible sensor, and (ii) during a second period of time, detecting a second sensor signal from a second region of the flexible sensor, wherein the second region differs from the first region, wherein operating the stimulator to provide a stimulus to the at least one nerve comprises: (i) during the first period of time, providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal, and (ii) during the second period of time, providing, to the second nerve via the second electrode, a second stimulus based on the second sensor signal, and wherein the second nerve differs from the first nerve.
However, Ward teaches a feedback system for a prosthesis (Abstract), wherein operating a sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises:
(i) during a first period of time, detecting a first sensor signal from a first region of the flexible sensor (paragraph [0066], "sensor 102 detects pressure corresponding to a handshake"), and
(ii) during a second period of time, detecting a second sensor signal from a second region of the flexible sensor (paragraph [0067]),
wherein operating the stimulator to provide a stimulus to the at least one nerve comprises:
(i) during the first period of time, providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal (paragraph [0066], "provide corresponding stimulation to the nerves 106 via the actuators 104"), and
(ii) during the second period of time, providing, to the second nerve via the second electrode, a second stimulus based on the second sensor signal (paragraph [0066], "provide corresponding stimulation to the nerves 106 via the actuators 104"; paragraphs [0062], [0067], [0134] disclose the use of more than one actuator), and
wherein the second nerve differs from the first nerve (paragraph [0057]).
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 Karr and Pivonka with the teachings of Ward to so that operating the sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises, during a first period of time, detecting a first sensor signal from a first region of the flexible sensor, and wherein operating the stimulator to provide a stimulus to the at least one nerve comprises, during the first period of time: (i) providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal, and (ii) providing, to the second nerve via the second electrode, a second stimulus based on the first sensor signal, wherein the second nerve differs from the first nerve, because doing so can restore sensation in a way that feels natural to the user (Ward, paragraph [0059]).
Ward does not explicitly disclose that the second region differs from the first region. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use different sensors in different regions, for the purpose of localizing detection of stimuli, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 20, the system of claim 18 is obvious over Karr and Pivonka, as explained above. Neither Karr nor Pivonka explicitly discloses that operating the sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises, during a first period of time, detecting a first sensor signal from a first region of the sensor, and wherein operating the stimulator to provide a stimulus to the at least one nerve comprises, during the first period of time: (i) providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal, and (ii) providing, to the second nerve via the second electrode, a second stimulus based on the first sensor signal, wherein the second nerve differs from the first nerve.
However, Ward teaches a feedback system for a prosthesis (Abstract), wherein operating a sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises: during a first period of time, detecting a first sensor signal from a first region of the flexible sensor (paragraph [0066], "sensor 102 detects pressure corresponding to a handshake"), and
wherein operating the stimulator to provide a stimulus to the at least one nerve comprises, during the first period of time:
(i) providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal (paragraph [0066], "provide corresponding stimulation to the nerves 106 via the actuators 104"), and
(ii) providing, to the second nerve via the second electrode, a second stimulus based on the first sensor signal (paragraph [0066], "provide corresponding stimulation to the nerves 106 via the actuators 104"; paragraphs [0062], [0067], [0134] disclose the use of more than one actuator),
wherein the second nerve differs from the first nerve (paragraph [0057]).
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 Karr, Hunter, and Pivonka with the teachings of Ward to so that operating the sensor to detect at least one of a pressure, a strain, a vibration, or a temperature comprises, during a first period of time, detecting a first sensor signal from a first region of the flexible sensor, and wherein operating the stimulator to provide a stimulus to the at least one nerve comprises, during the first period of time: (i) providing, to the first nerve via the first electrode, a first stimulus based on the first sensor signal, and (ii) providing, to the second nerve via the second electrode, a second stimulus based on the first sensor signal, wherein the second nerve differs from the first nerve, because doing so can restore sensation in a way that feels natural to the user (Ward, paragraph [0059]).
Regarding claim 22, the system of claim 14 is obvious over Karr and Hunter, as explained above. Neither Karr nor Hunter explicitly discloses that the controller is additionally configured to: operate in a first mode, wherein operating in the first mode comprises: operating the sensor to detect a first at least one of a pressure, a strain, a temperature, or a vibration; determining, based on the detected first at least one of a pressure, a strain, a temperature, or a vibration, a first stimulus waveform according to a first mapping; and operating the stimulator to provide the determined first stimulus waveform; receive a mode change instruction; and responsive to receiving the mode change instruction, operate in a second mode, wherein operating in the second mode comprises: operating the sensor to detect a second at least one of a pressure, a strain, a temperature, or a vibration; operating the sensor to detect a second at least one of a pressure, a strain, a temperature, or a vibration; determining, based on the detected second at least one of a pressure, a strain, a temperature, or a vibration, a second stimulus waveform according to a second mapping, wherein the second mapping differs from the first mapping; and operating the stimulator to provide the determined second stimulus waveform.
However, Ward teaches a feedback system for a prosthesis (Abstract) comprising a controller (Fig. 1, paragraph [0062], processor 108) configured to:
operate in a first mode, wherein operating in the first mode comprises:
operating the sensor to detect a first at least one of a pressure, a strain, a temperature, or a vibration (paragraph [0075], "the training process includes monitoring sensor 102 and neural sensor 110 outputs while the user performs actions such as everyday tasks");
determining, based on the detected first at least one of a pressure, a strain, a temperature, or a vibration, a first stimulus waveform according to a first mapping (paragraphs [0073]-[0074]); and
operating the stimulator to provide the determined first stimulus waveform (paragraph [0066]).
Ward further teaches that the process is repeated for several actuators (paragraphs [0062], [0067], [0134]).
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 Karr and Hunter with the teachings of Ward to operate in a first mode, wherein operating in the first mode comprises: operating the sensor to detect a first at least one of a pressure, a strain, a temperature, or a vibration; determining, based on the detected first at least one of a pressure, a strain, a temperature, or a vibration, a first stimulus waveform according to a first mapping; and operating the stimulator to provide the determined first stimulus waveform; receive a mode change instruction; and responsive to receiving the mode change instruction, operate in a second mode, wherein operating in the second mode comprises: operating the sensor to detect a second at least one of a pressure, a strain, a temperature, or a vibration; operating the sensor to detect a second at least one of a pressure, a strain, a temperature, or a vibration; determining, based on the detected second at least one of a pressure, a strain, a temperature, or a vibration, a second stimulus waveform according to a second mapping, wherein the second mapping differs from the first mapping; and operating the stimulator to provide the determined second stimulus waveform, because doing so can restore sensation in a way that feels natural to the user (Ward, paragraph [0059]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Eckmiller (US 6530954 B1) discloses an adaptive sensory-motor encoder comprising sensors 9 configured to detect a pressure and a subcutaneous stimulator configured to evoke a perception of touch (column 6, lines 18-19, "The user receives, on the one hand, signals as stimulation pulses or sensory perceptions from the encoder"; column 7, lines 9-16).
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/CHRISTINE SISON/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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