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 .
Notice of Amendment
In response to the amendment filed on 6/5/2026, amended claims 1, 4, 7-8, 11-12, 16, 19, 23-24, and 27 are acknowledged. Claims 1-9, 11-14, 16-17, 19-24, and 27-29 remain pending. The following new and reiterated grounds of rejection are set forth:
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 12 and 27 recite the limitation “an external device provided outside of a body is mounted on a surface of the vascular neural interface device”, which renders the claim indefinite because it is unclear how the external device can be both external and also mounted on a surface of the vascular neural interface, which is inserted within a blood vessel as specified in claims 1 and 16.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 12-13, 16-17, and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chavan et al. (US Publication No. 2010/0049275 A1) (cited by Applicant).
Regarding claim 1, Chavan et al. discloses a vascular neural interface device for at least one of stimulating or recording from the nervous system, comprising:
a package (100, 300) configured to be inserted within a blood vessel (see [0050] – “FIG. 3 illustrates a chronically-implanted device 300 in the form of a stent placed within a vessel 322 in which the device includes an encapsulated electronics platform”), wherein the package includes:
at least one transducer (102) (see [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities. For example, some transceiver embodiments use a telemetry coil to wirelessly communicate with a programmer or another external or internal device. Some communication modules have transducers for use to communicate through ultrasound signals”),
at least one electrode (106, 108) (see [0041] – “In various embodiments, at least one electrode is integrated with or otherwise formed on the housing of the device such that the neural stimulation circuitry applies electrical stimulation through the electrode on the housing”), and
at least one integrated circuit (104) (see [0071] – “MEMS technology integrates mechanical elements, sensors, actuators, and electronics on a common silicon substrate using microfabrication technology. MEMS combines silicon-based microelectronics with microsensors and microactuators to provide a complete system on a chip. The micromechanical components are fabricated using micromachining processes that are compatible with the integrated circuit process sequences. Parts of the silicon wafer are selectively etched away or new structural layers are added to form the mechanical and electromechanical devices. According to various embodiments of the chronically-implanted device, at least one of the components (i.e. the power circuitry, the communication circuitry, the control circuitry, the stimulation circuitry, and the sensing circuitry) are integrated onto silicon MEMS technology to reduce size”),
wherein the at least one transducer is configured to at least one of receive or transmit a wireless signal which is used to at least one of provide energy to or communicate with the at least one integrated circuit to record information from the nervous system using recording electrodes of the at least one electrode of the package (see [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities. For example, some transceiver embodiments use a telemetry coil to wirelessly communicate with a programmer or another external or internal device. Some communication modules have transducers for use to communicate through ultrasound signals”, [0040] – “According to various embodiments, the controller is adapted to trigger the sensing circuit, the stimulating circuit, or the sensing and stimulating circuits. According to one embodiment, the controller is used to manage system power by controlling power flow between the power circuitry and other system components”, [0041] – “For example, the sensing circuit 108 can be used to detect and process ANS nerve activity and/or surrogate parameters such as blood pressure, respiration and the like, to determine the ANS activity”, [0059] – “Some device embodiments sense electrical signals with electrode(s)”, and [0074] – “Some embodiments use ultrasound transducers for communications, and some embodiments use ultrasound transducers to recharge the IMD. Thus, the programmer can be used to adjust the programmed therapy provided by the IMD, and the IMD can report device data (such as battery data and lead resistance) and therapy data (such as sense and stimulation data) to the programmer using radio telemetry, for example”).
Regarding claim 2, Chavan et al. discloses the at least one transducer is a piezoelectric transducer configured to interface with ultrasound energy (see [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities. For example, some transceiver embodiments use a telemetry coil to wirelessly communicate with a programmer or another external or internal device. Some communication modules have transducers for use to communicate through ultrasound signals” and [0056] – “Examples of ultrasonic transducers include an acoustic, piezoelectric, electrostatic, and magnetostrictive devices”).
Regarding claim 12 as best understood, Chavan et al. discloses an external device provided outside of a body is mounted on a surface of the vascular neural interface device at a particular location outside of the body for powering and data transmission thereof (see [0038] – “As such, one embodiment of the chronically-implanted device 100 provides a combined power/communication link 112 between the power/communication circuit 102 and the external device 110”).
Regarding claim 13, Chavan et al. discloses the external device is an ultrasound transducer (see Figure 8 and [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities. For example, some transceiver embodiments use a telemetry coil to wirelessly communicate with a programmer or another external or internal device. Some communication modules have transducers for use to communicate through ultrasound signals” and [0056] – “As illustrated in FIG. 8, some embodiments of the chronically-implanted device is powered by a small rechargeable battery adapted to be recharged using ultrasound waves 836 from an ultrasound power source 838. The use of ultrasound allows the device to be recharged remotely. The illustrated device 800 includes an ultrasound transducer 840, or an array of transducers, to convert the ultrasound signals into an electrical signal. Examples of ultrasonic transducers include an acoustic, piezoelectric, electrostatic, and magnetostrictive devices”).
Regarding claim 16, Chavan et al. discloses a method for at least one of stimulating or recording information of a nervous system, comprising:
providing vascular neural interface device which includes a package configured to be inserted within a blood vessel, wherein the package includes:
at least one transducer (102) (see [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities. For example, some transceiver embodiments use a telemetry coil to wirelessly communicate with a programmer or another external or internal device. Some communication modules have transducers for use to communicate through ultrasound signals”),
at least one electrode (106, 108) (see [0041] – “In various embodiments, at least one electrode is integrated with or otherwise formed on the housing of the device such that the neural stimulation circuitry applies electrical stimulation through the electrode on the housing”), and
at least one integrated circuit (104) (see [0071] – “MEMS technology integrates mechanical elements, sensors, actuators, and electronics on a common silicon substrate using microfabrication technology. MEMS combines silicon-based microelectronics with microsensors and microactuators to provide a complete system on a chip. The micromechanical components are fabricated using micromachining processes that are compatible with the integrated circuit process sequences. Parts of the silicon wafer are selectively etched away or new structural layers are added to form the mechanical and electromechanical devices. According to various embodiments of the chronically-implanted device, at least one of the components (i.e. the power circuitry, the communication circuitry, the control circuitry, the stimulation circuitry, and the sensing circuitry) are integrated onto silicon MEMS technology to reduce size”);
with the at least one transducer, facilitating at least one of a receipt or a transmission of a wireless signal (see [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities”); and
at least one of providing energy to or communicating with the at least one integrated circuit which is configured to record information of the nervous system using recording electrodes of the at least one electrode of the package (see [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities. For example, some transceiver embodiments use a telemetry coil to wirelessly communicate with a programmer or another external or internal device. Some communication modules have transducers for use to communicate through ultrasound signals”, [0040] – “According to various embodiments, the controller is adapted to trigger the sensing circuit, the stimulating circuit, or the sensing and stimulating circuits. According to one embodiment, the controller is used to manage system power by controlling power flow between the power circuitry and other system components”, [0041] – “For example, the sensing circuit 108 can be used to detect and process ANS nerve activity and/or surrogate parameters such as blood pressure, respiration and the like, to determine the ANS activity”, [0059] – “Some device embodiments sense electrical signals with electrode(s)”, and [0074] – “Some embodiments use ultrasound transducers for communications, and some embodiments use ultrasound transducers to recharge the IMD. Thus, the programmer can be used to adjust the programmed therapy provided by the IMD, and the IMD can report device data (such as battery data and lead resistance) and therapy data (such as sense and stimulation data) to the programmer using radio telemetry, for example”).
Regarding claim 17, Chavan et al. discloses at least one of:
the at least one transducer is a piezoelectric transducer configured to interface with ultrasound energy (see [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities. For example, some transceiver embodiments use a telemetry coil to wirelessly communicate with a programmer or another external or internal device. Some communication modules have transducers for use to communicate through ultrasound signals” and [0056] – “Examples of ultrasonic transducers include an acoustic, piezoelectric, electrostatic, and magnetostrictive devices”),
the package is a flexible circuit board, or
the at least one flexible circuit board includes polyimide and metal interconnects.
Regarding claim 27 as best understood, Chavan et al. discloses an external device provided outside of a body is mounted on a surface of the vascular neural interface device at a particular location outside of the body for powering and data transmission thereof (see [0038] – “As such, one embodiment of the chronically-implanted device 100 provides a combined power/communication link 112 between the power/communication circuit 102 and the external device 110”).
Regarding claim 28, Chavan et al. discloses the external device is an ultrasound transducer (see Figure 8 and [0038] – “Furthermore, with respect to device embodiments that include separate power and communication links, the power link is capable of being wireless (e.g. ultrasound), and the communication link is independently capable of being wireless (e.g. ultrasound). For example, the circuit 102 in the illustrated device can include a transceiver and associated circuitry for use to communicate with a programmer or another external or internal device. Various embodiments have wireless communication capabilities. For example, some transceiver embodiments use a telemetry coil to wirelessly communicate with a programmer or another external or internal device. Some communication modules have transducers for use to communicate through ultrasound signals” and [0056] – “As illustrated in FIG. 8, some embodiments of the chronically-implanted device is powered by a small rechargeable battery adapted to be recharged using ultrasound waves 836 from an ultrasound power source 838. The use of ultrasound allows the device to be recharged remotely. The illustrated device 800 includes an ultrasound transducer 840, or an array of transducers, to convert the ultrasound signals into an electrical signal. Examples of ultrasonic transducers include an acoustic, piezoelectric, electrostatic, and magnetostrictive devices”).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3-4, 7-9, 19, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan et al., further in view of Pivonka et al. (US Patent No. 10,238,872 B2) (previously cited).
Regarding claim 3, it is noted Chavan et al. does not specifically teach the package is a flexible circuit board. However, Pivonka et al. teaches the package is a flexible circuit board (see Figure 8 and col. 23, lines 26-30 – “In the embodiment of FIG. 8, implantable device 200 comprises antenna 240 which is positioned and/or constructed on substrate 211, which is surrounded by implantable housing 210. Substrate 211 can comprise a printed circuit board (PCB), a flexible PCB, or other substrate”). 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 device of Chavan et al. to include the package is a flexible circuit board, as disclosed in Pivonka et al., so as to allow the package to be compacted to ease delivery through an implantation tool (see Pivonka et al.: col. 21, lines 63-67).
Regarding claims 4 and 19, the combination of Chavan et al. and Pivonka et al. teaches the package is configured to be deployed with a catheter into the blood vessel by: rolling the package around the catheter to form a rolled catheter configuration (see Pivonka et al.: col. 16, line 64-col. 17, line 3 – “Apparatus 10 can further comprise tool 80 which can be constructed and arranged to implant one or more implantable devices in a minimally invasive way, such as when tool 80 comprises a needle through which an implantable device 200 can be implanted in the patient P as shown. In some embodiments, tool 80 comprises a needle; a laparoscope or an endoscope” and col. 21, lines 63-67 – “This flexible substrate implementation can be configured to allow antenna 240 to be compacted (e.g. rolled up into a cylindrical shape), such as to ease delivery through a lumen of a needle (e.g. a large-bore hypodermic needle) or other implantation tool”), and providing the rolled catheter configuration at a predetermined location by expanding the catheter configuration against walls of the blood vessel (see Chavan et al.: [0049] – “Embodiments of the stent-like, chronically-implanted device include balloon-expandable stents and self-expanding stents. The expanded stent applies pressure against the interior of the vessel to widen the vessel. The catheter is removed, leaving the expanded stent securely in place”).
Regarding claims 7 and 22, Pivonka et al. teaches the at least one integrated circuit has a configuration and dimensions to be mechanically flexible (see Figure 8 and col. 23, lines 26-30 – “In the embodiment of FIG. 8, implantable device 200 comprises antenna 240 which is positioned and/or constructed on substrate 211, which is surrounded by implantable housing 210. Substrate 211 can comprise a printed circuit board (PCB), a flexible PCB, or other substrate”).
Regarding claims 8 and 23 as best understood, it is noted Chavan et al. does not specifically teach the at least one transducer is configured to facilitate powering and communication with an external device that is rotationally invariant in the blood vessel. However, Pivonka et al. teaches the at least one transducer is configured to facilitate powering and communication with an external device, and wherein the at least one transducer is configured to be rotationally invariant in the blood vessel (see col. 21, lines 42-47 – “In some embodiments, antenna 240 comprises multiple antennas positioned in orthogonal or other non-planar orientations (e.g. with respect to each other) to ensure that an incoming power transmission is captured regardless of the position or orientation of antennas 240 with respect to the transmitting external antenna 540”). 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 device and method of Chavan et al. to include the at least one transducer is configured to facilitate powering and communication with an external device that is rotationally invariant in the blood vessel, as disclosed in Pivonka et al., so as to ensure incoming power transmission is capture regardless of the position or orientation of the transducer relative to the external device (see Pivonka et al.: col. 21, lines 42-47).
Regarding claim 9, it is noted Chavan et al. does not specifically teach a data transmission arrangement which is configured to transmit data at least one (i) to an external device using an amplitude shift keying procedure, or (ii) from the external device using at least one of the load shift keying procedure or a modulated backscatter procedure. However, Pivonka et al. teaches a data transmission arrangement which is configured to transmit data at least one (i) to an external device using an amplitude shift keying procedure (see Figure 18 and col. 11, lines 29-33 – “FIG. 18 is a time versus signal chart of a communication system of an external system configured for amplitude shift keying (ASK) with data encoded in the pulse width modulation scheme, consistent with the present inventive concepts” and col. 34, lines 47-52 – “For example, amplitude shift-keying can be used with data encoded in the pulse-width (ASK-PW). In this method, the amplitude of the power carrier is modulated with minimal depth, which minimizes the impact on power delivery to the implantable device 200 as desired”), or (ii) from the external device using at least one of the load shift keying procedure or a modulated backscatter procedure (see col. 35, lines 22-25 – “The transmission module can comprise a backscattering link, an active transmitter, and/or a body conduction-based transmitter, as described herein”). 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 device of Chavan et al. to include a data transmission arrangement which is configured to transmit data at least one (i) to an external device using an amplitude shift keying procedure, or (ii) from the external device using at least one of the load shift keying procedure or a modulated backscatter procedure, as disclosed in Pivonka et al., so as to minimize effects of power delivery, allowing for higher power transfer efficiency and therefore less tissue heating due to the power carrier (see Pivonka et al.: col. 36, lines 47-50).
Regarding claim 24, it is noted Chavan et al. does not specifically teach transmitting at least one of: (a) data at least one of to an external device using an amplitude shift keying procedure or (ii) from the external device using at least one of the load shift keying procedure or a modulated backscatter procedure, or (b) signals to locate the vascular neural interface device with at least one chamber on the package containing microbubbles. However, Pivonka et al. teaches transmitting at least one of: (a) data at least one of to an external device using an amplitude shift keying procedure (see Figure 18 and col. 11, lines 29-33 – “FIG. 18 is a time versus signal chart of a communication system of an external system configured for amplitude shift keying (ASK) with data encoded in the pulse width modulation scheme, consistent with the present inventive concepts” and col. 34, lines 47-52 – “For example, amplitude shift-keying can be used with data encoded in the pulse-width (ASK-PW). In this method, the amplitude of the power carrier is modulated with minimal depth, which minimizes the impact on power delivery to the implantable device 200 as desired”) or (ii) from the external device using at least one of the load shift keying procedure or a modulated backscatter procedure (see col. 35, lines 22-25 – “The transmission module can comprise a backscattering link, an active transmitter, and/or a body conduction-based transmitter, as described herein”), or (b) signals to locate the device with at least one chamber on the package containing microbubbles. 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 method of Chavan et al. to include transmitting at least one of: (a) data at least one of to an external device using an amplitude shift keying procedure or (ii) from the external device using at least one of the load shift keying procedure or a modulated backscatter procedure, or (b) signals to locate the device with at least one chamber on the package containing microbubbles, as disclosed in Pivonka et al., so as to minimize effects of power delivery, allowing for higher power transfer efficiency and therefore less tissue heating due to the power carrier (see Pivonka et al.: col. 36, lines 47-50).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan et al. and Pivonka et al., further in view of Boyden et al. (US Publication No. 2016/0000590 A1) (cited by Applicant).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan et al., further in view of Boyden et al. (US Publication No. 2016/0000590 A1) (cited by Applicant).
Regarding claims 5 and 20, it is noted neither Chavan et al. nor Pivonka et al. specifically teach the at least one flexible circuit board includes polyimide and metal interconnects. However, Boyden et al. teaches the at least one flexible circuit board includes polyimide and metal interconnects (see [0041] – “The other flexible, nonconductive structural elements of the active intravascular device can be made of a suitable polymer (e.g. polyimide, kapton, parylene, etc.). The outer surface of electrode sites exposed to the body can be made of any suitable material, e.g. metals such as Pt, Pt/Ir, stainless steel, conducting polymers such as PEDOT or polypyrrole, carbon nanotubes, graphene and others as known to those skilled in the art”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, 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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan et al. and Pivonka et al., further in view of Bolea et al. (US Publication No. 2009/0228065 A1) (previously cited).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan et al., further in view of Bolea et al. (US Publication No. 2009/0228065 A1) (previously cited).
Regarding claims 6 and 21, it is noted neither Chavan et al. nor Pivonka et al. specifically teach the at least one electrode spans fully between opposing sides of the at least one flexible circuit board, such that when unrolled in the blood vessel, the at least one electrode and the at least one flexible circuit board collectively span a circumference of the blood vessel. However, Bolea et al. teaches the at least one electrode spans fully between opposing sides of the at least one flexible circuit board, such that when unrolled in the blood vessel, the at least one electrode and the at least one flexible circuit board collectively span a circumference of the blood vessel (see [0016] – “The base has a length sufficient to extend around at least a substantial portion of the circumference of a blood vessel, usually an artery, more usually a carotid artery at or near the carotid sinus. By "substantial portion," it is meant that the base will extend over at least 25% of the vessel circumference, usually at least 50%, more usually at least 66%, and often at least 75% or over the entire circumference. Usually, the base is sufficiently elastic to conform to said circumference or portion thereof when placed therearound. The electrode connected to the base is oriented at least partly in the circumferential direction and is sufficiently stretchable to both conform to the shape of the carotid sinus when the base is conformed thereover and accommodate changes in the shape and size of the sinus as they vary over time with heart pulse and other factors, including body movement which causes the blood vessel circumference to change”). 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 device and method of Chavan et al. and Pivonka et al. to include the at least one electrode spans fully between opposing sides of the at least one flexible circuit board, such that when unrolled in the blood vessel, the at least one electrode and the at least one flexible circuit board collectively span a circumference of the blood vessel, as disclosed in Bolea et al., so as to conform to the shape of the blood vessel and accommodate changes in the shape and size of the vessel as they vary over time with heart pulse and other factors (see Bolea et al.: [0016]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan et al., further in view of Shea et al. (WO 2020/151179 A1) (previously cited).
Regarding claim 11, it is noted Chavan et al. does not specifically teach the package comprises at least one chamber which includes microbubbles. However, Shea et al. teaches at least one chamber is included in the package containing microbubbles (see [0110] – “In certain embodiments, the implantable device 131 (active or not) can have a non-linear effect on ultrasound sonication. This can be done by introducing materials or substances with non-linear ultrasonic property, for example, micro-bubbles are well known to have non-linear effect of ultrasound. These non-linear properties will generate harmonics of the reflected ultrasound wave”). 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 device of Chavan et al. to include at least one chamber is included in the package containing microbubbles, as disclosed in Shea et al., so as to introduce a non-linear effect on ultrasound sonication and generate harmonics of the reflected ultrasound wave so that the implantable device can be identified from other structures by selecting the frequency spectrum of the harmonic signals (see Shea et al.: [0110]-[0111]).
Claim(s) 14 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chavan et al., further in view of Maharbiz et al. (US Publication No. 2019/0321644 A1) (previously cited).
Regarding claims 14 and 29, it is noted Chavan et al. does not specifically teach the ultrasound transducer is a two-dimension array of transducers provided on or in a wearable patch device. However, Maharbiz et al. teaches the ultrasound transducer is a two-dimension array of transducers provided on or in a wearable patch device (see [0121] – “In some embodiments, the interrogator is external (i.e., not implanted). By way of example, the external interrogator can be a wearable, which may be fixed to the body by a strap or adhesive. In another example, the external interrogator can be a wand, which may be held by a user (such as a healthcare professional). In some embodiments, the interrogator can be held to the body via suture, simple surface tension, a clothing-based fixation device such as a cloth wrap, a sleeve, an elastic band, or by sub-cutaneous fixation. The transducer or transducer array of the interrogator may be positioned separately from the rest of the transducer. For example, the transducer array can be fixed to the skin of a subject at a first location (such as proximal to one or more implanted devices), and the rest of the interrogator may be located at a second location, with a wire tethering the transducer or transducer array to the rest of the interrogator”). 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 device and method of Chavan et al. to include the ultrasound transducer is a two-dimension array of transducers provided on or in a wearable patch device, as disclosed in Maharbiz et al., so as to allow the external device to be wearable and fixed to the body (see Maharbiz et al.: [0121]).
Response to Arguments
Applicant's arguments filed 6/5/2026 have been fully considered but they are not persuasive.
Applicant argues that claims 12 and 27 have been amended to address the rejections under 35 U.S.C. 112(b). However, the amendments do not address the unclear limitation “an external device provided outside of a body is mounted on a surface of the vascular neural interface device”. It is unclear how the external device can be both external and also mounted on a surface of the vascular neural interface, which is inserted within a blood vessel as specified in claims 1 and 16. Looking at Applicant’s specification and disclosure, the closest description of this limitation appears to be what is shown in Figure 6 and described in [0045] of the original disclosure – external device 605 is linked to the implanted vascular neural interface 630 (implanted in vein 625 or artery 620) through an acoustic coupling gel 610 and 615. However, this is markedly different being mounted on a surface of the vascular neural interface device. Moreover, it is unclear if that is what Applicant intended to claim, and limitations from the specification are not read into the claims.
In response to Applicant’s argument with respect to independent claims 1 and 16 that Chavan fails to disclose a wireless signal is used to provide energy to and/or communicate with the at least one integrated circuit to record information from the nervous system using recording electrodes of the at least one electrode of the package, the Examiner respectfully disagrees and notes that Chavan describes wireless power and communication links, for example using ultrasound, to communicate with a programmer of another external or internal device (see [0038]). Communication circuitry 102 communicates with controller circuitry 104 (i.e. “integrated circuit”) to provide power, and controller circuitry 104 triggers sensing circuit 108 to detect and process ANS nerve activity (“information from the nervous system”) (see [0040]-[0041]). The sensing circuit can include electrodes (“recording electrodes”) to sense the electrical signals (see [0059]).
In response to Applicant's argument with respect to claim 11 that Shea cannot be equivalent to a package that is configured to be inserted within a blood vessel, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The present rejection does not rely on Shea to teach package configured to be inserted within a blood vessel, since this limitation is already taught by Chavan. Instead, Shea teaches an implantable package that includes microbubbles (see [0110]). Applicant’s arguments do not dispute that Shea teaches an implantable package that includes microbubbles.
In response to Applicant’s argument with respect to claim 12 that Chavan does not teach “an external device provided outside of a body is mounted on a surface of the vascular neural interface device at a particular location outside of the body for powering and data transmission”, the Examiner notes that the “mounted on a surface of the vascular neural interface device” is indefinite, as outlined in the rejection under 35 U.S.C. 112(b), because it is unclear how the external device can be both external and also mounted on a surface of the vascular neural interface, which is inserted within a blood vessel as specified in claims 1 and 16. Therefore, it is not possible to map prior art to this contradictory limitation. Chavan describes an external device 110 provided outside of a body at a particular location outside of the body for powering and data transmission (see [0038]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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