DETAILED ACTION
This action is pursuant to claims filed on 05/23/2025. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the detuning mitigation layer in claims 5 and 18 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Reference character 566 in paragraph [0045] in the specification does not appear in the figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-3, 5-9, and 11-12 are objected to because of the following informalities:
In claim 2, line 1, “claim 1 and further comprising” should read “claim 1, further comprising”
In claim 3, line 1, “claim 2 and further comprising” should read “claim 2, further comprising”
In claim 5, line 1, “claim 2 and further comprising” should read “claim 2, further comprising”
In claim 6, line 1, second detuning” should read “the second detuning”
In claim 7, line 1, “claim 6 and further comprising” should read “claim 6, further comprising”
In claim 8, line 1, “second insulating layers” should read “the second insulating layers”
In claim 9, line 6, “the pointed tips” should read “pointed tips”, as no pointed tips have been introduced in the claims yet for the second subset of the plurality of cells
In claim 11, line 1, “second sensors” should read “the second sensors”
In claim 12, line 1, “second sensors” should read “the second sensors”
Appropriate correction is required.
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 2-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the claim recites the limitation “a signal representing the physical parameter” in line 8. It is unclear if this limitation is meant to refer to the signal representing the physical parameter from claim 1, lines 12-13, or a different signal. If it is meant to refer to the signal from claim 1, it needs to refer back to it. If it is meant to refer to a different signal, it needs to be distinguished from the signal from claim 1. For purposes of examination, it is being interpreted as referring to the signal from claim 1. Claims 3-17 are also rejected due to their dependence on claim 1.
Regarding claim 6, the claim recites the limitation “the prosthetic heart valve of claim 5” in line 1. This limitation is unclear, as the prosthetic valve in claim 5 has not been introduced as a heart valve. Therefore, it is unclear if the valve of claim 5 is meant to be a heart valve, or if claim 6 is meant to only apply to a heart valve. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as any type of prosthetic valve. Claims 7-8 are also rejected due to their dependence on claim 6.
Regarding claim 17, the claim recites the limitation “the prosthetic heart valve assembly” in line 7. It is unclear if this limitation is meant to refer to the prosthetic valve assembly from line 2, or a different prosthetic heart valve assembly. If it is meant to refer to the assembly from line 2, it needs to properly refer back to it. If it is meant to refer to a different prosthetic heart valve assembly, it needs to be properly introduced and distinguished from the prosthetic valve assembly from line 2. For purposes of examination, it is being interpreted as referring to the prosthetic valve assembly from line 2.
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.
Claims 1-3, 9-13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Braido (US 20160045316) in view of Gross (WO 2022149130).
Regarding independent claim 1, Braido teaches a prosthetic valve ([0002]: “The present invention relates to heart valve replacement”) comprising:
a flexible frame disposed along a frame axis (Stent 410 is a frame disposed along a frame axis (the top-to-bottom axis of the stent)) and deformable about the frame axis between a crimped state and an expanded state ([0005]: “Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent. There are two types of stents on which the valve structures are ordinarily mounted: a self-expanding stent and a balloon-expandable stent. To place such valves into a delivery apparatus and ultimately into a patient, the valve must first be collapsed or crimped to reduce its circumferential size”. The collapsed state is the crimped state, and the regular state is the expanded state.), the frame comprising:
a first end (Distal end 404);
a second end oppositely disposed from the first end (Proximal end 402); and
a network of interconnected struts defining a plurality of cells ([0038]: “Stent 410 may include a plurality of struts 412 forming a plurality of cells 414”);
a first circuit mounted on the frame ([0031]: “FIGS. 3A and 3B illustrate one example of a sensor for diagnostic usage … Capacitive plate 306 is sensitive to pressure and experiences nanometer scale deflections due to changes in blood pressure acting on the sensor 300. These nanometer scale deflections result in a change in the resonant frequency of circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 30”; [0064]: “It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments”. The sensor 300 can be used as the sensors 450C’ in Fig. 4C shown on the stent 410.), the first circuit comprising: a first inductor coil ([0032]: “The sensor 300 can be electromagnetically coupled to a transmitting antenna (not shown). Consequently, a current is induced in the sensor 300, which oscillates at the resonant frequency of the circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 307”).
However, Braido does not teach the first inductor coil attached to and tracing a first subset of the struts such that the first inductor coil outlines a first subset of the plurality of cells.
Gross discloses a prosthetic aortic valve. Specifically, Gross teaches the first inductor coil attached to and tracing a first subset of the struts such that the first inductor coil outlines a first subset of the plurality of cells (Fig. 14C; Page 84, line 29 – Page 85, line 4: “Fig. 14C shows a prosthetic aortic valve 820C. In this configuration, prosthetic- valve coil 836 is a first prosthetic-valve coil 836C, the plurality of stent struts 831 is a first plurality of stent struts 831, and plurality 835 of stent cells 833 is a first plurality 835C of stent cells 833. Prosthetic aortic valve 820 further comprises a second prosthetic-valve coil 836D, which is in non-wireless electrical communication with cathode 54 and anode 57, and is coupled to a second plurality of stent struts 831, running along stent struts 831 so as to surround a second plurality 835D of stent cells 833”). Braido and Gross are analogous art as they are both related to the same field of endeavor of prosthetic heart valves.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the inductor coil outlining the cells from Gross into the device from Braido as it is another known formation of the inductor coil in a prosthetic heart valve, and therefore would be a simple substitution that would yield predictable results.
The Braido/Gross combination teaches a first sensor in electrical communication with the first inductor coil (Braido, Sensors 450C’);
wherein the first sensor is configured to sense a physical parameter (Braido, [0036]: “Sensors 300 may be used to measure one or more parameters including real time blood pressure, flow velocity (e.g., blood flow), apposition forces based on pressure changes due to interaction between two surfaces of the prosthetic valve, impingement forces, which are correlated to pressure changes caused by the interaction between a surface of the prosthetic device and native tissue, cardiac output, effective orifice area, pressure drop, and aortic regurgitation. Sensor 300 provides time-resolved pressure data which may be correlated to the parameters of interest based on empirical correlations that have been presented in literature. In some examples, sensors 300 may function similar to piezo-electric strain gauges to directly measure a parameter. Other parameters may be indirectly calculated. One specific method of using sensors 300 to measure aortic regurgitation”) and generate a signal representing the physical parameter (Braido, [0032]: “The sensor 300 can be electromagnetically coupled to a transmitting antenna (not shown). Consequently, a current is induced in the sensor 300, which oscillates at the resonant frequency of the circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 307. This oscillation causes a change in the frequency spectrum of the transmitted signal. From this change, the bandwidth and resonant frequency of the particular sensor may be determined, from which the corresponding blood pressure can be calculated. Time-resolved blood pressure measurements can be correlated to flow using empirical relationships established in clinical literature”. The transmitted signal is the signal.).
Regarding claim 2, the Braido/Gross combination teaches the prosthetic valve of claim 1 and further comprising: a second circuit mounted on the frame (Braido, Sensors 450C in Fig. 4C; [0031]: “FIGS. 3A and 3B illustrate one example of a sensor for diagnostic usage … Capacitive plate 306 is sensitive to pressure and experiences nanometer scale deflections due to changes in blood pressure acting on the sensor 300. These nanometer scale deflections result in a change in the resonant frequency of circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 30”; [0064]: “It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments”. The sensor 300 can be used as the sensors 450C in Fig. 4C shown on the stent 410.), the second circuit comprising: a second inductor coil attached to and tracing a second subset of the struts such that the second inductor coil outlines a second subset of the plurality of cells (Braido, [0032]: “The sensor 300 can be electromagnetically coupled to a transmitting antenna (not shown). Consequently, a current is induced in the sensor 300, which oscillates at the resonant frequency of the circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 307”; [0042]: “The first group of sensors 450C may be configured to monitor one or more parameters at the inflow end of heart valve 400C, while the second group of sensors 450C′ may be configured to monitor one or more parameters at the outflow end of heart valve 400C”. It is clear that the second set of sensors that are used to measure parameters at the second end would outline a second subset of the struts, as it is meant to measure a different location than the first set of sensors.; Gross, Fig. 14C; Page 84, line 29 – Page 85, line 4: “Fig. 14C shows a prosthetic aortic valve 820C. In this configuration, prosthetic- valve coil 836 is a first prosthetic-valve coil 836C, the plurality of stent struts 831 is a first plurality of stent struts 831, and plurality 835 of stent cells 833 is a first plurality 835C of stent cells 833. Prosthetic aortic valve 820 further comprises a second prosthetic-valve coil 836D, which is in non-wireless electrical communication with cathode 54 and anode 57, and is coupled to a second plurality of stent struts 831, running along stent struts 831 so as to surround a second plurality 835D of stent cells 833”); and a second sensor in electrical communication with the second inductor coil (Braido, Sensors 450C); wherein the second sensor is configured to sense the physical parameter (Braido, [0036]: “Sensors 300 may be used to measure one or more parameters including real time blood pressure, flow velocity (e.g., blood flow), apposition forces based on pressure changes due to interaction between two surfaces of the prosthetic valve, impingement forces, which are correlated to pressure changes caused by the interaction between a surface of the prosthetic device and native tissue, cardiac output, effective orifice area, pressure drop, and aortic regurgitation. Sensor 300 provides time-resolved pressure data which may be correlated to the parameters of interest based on empirical correlations that have been presented in literature. In some examples, sensors 300 may function similar to piezo-electric strain gauges to directly measure a parameter. Other parameters may be indirectly calculated. One specific method of using sensors 300 to measure aortic regurgitation”) and generate a signal representing the physical parameter (Braido, [0032]: “The sensor 300 can be electromagnetically coupled to a transmitting antenna (not shown). Consequently, a current is induced in the sensor 300, which oscillates at the resonant frequency of the circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 307. This oscillation causes a change in the frequency spectrum of the transmitted signal. From this change, the bandwidth and resonant frequency of the particular sensor may be determined, from which the corresponding blood pressure can be calculated. Time-resolved blood pressure measurements can be correlated to flow using empirical relationships established in clinical literature”. The transmitted signal is the signal.).
Regarding claim 3, the Braido/Gross combination teaches the prosthetic valve of claim 2 and further comprising: at least a first post assembly extending axially away from the first end; and at least a second post assembly extending axially away from the second end; wherein the first sensor is mounted on the first post assembly; and wherein the second sensor is mounted on the second post assembly (Braido, Fig. 4C shows the first and second sensors on posts extending away from the ends (see annotated Fig. 4C below).
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Regarding claim 9, the Braido/Gross combination teaches the prosthetic valve of claim 2, wherein: the first inductor coil is attached to the first subset of struts at pointed tips of each of the first subset of the plurality of cells (Braido, See annotated Fig. 4C below, which indicates the pointed tips of the cells. Since Gross discloses the inductor coils being disposed along the struts outlining the cells, it is obvious that it includes the pointed tips (Gross, Fig. 14C; Page 84, line 29 – Page 85, line 4: “Fig. 14C shows a prosthetic aortic valve 820C. In this configuration, prosthetic- valve coil 836 is a first prosthetic-valve coil 836C, the plurality of stent struts 831 is a first plurality of stent struts 831, and plurality 835 of stent cells 833 is a first plurality 835C of stent cells 833. Prosthetic aortic valve 820 further comprises a second prosthetic-valve coil 836D, which is in non-wireless electrical communication with cathode 54 and anode 57, and is coupled to a second plurality of stent struts 831, running along stent struts 831 so as to surround a second plurality 835D of stent cells 833”)); the first inductor coil is removably attached to the pointed tips of each of the first subset of the plurality of cells by a first plurality of sutures (Braido, [0042]: “Sensors may also be disposed on either the inner diameter, the outer diameter or a combination of both and may be sutured, glued, welded, or made integral with the stent”; [0035]: “nitinol loops 310 may be removed and replaced with suture holes for attachment, and cantilevers or other structural members may be added”. The inductor coils are part of the sensors, therefore can be sutured as the attachment mechanism); the second inductor coil is attached to the second subset of struts at the pointed tips of each of the second subset of the plurality of cells (Braido, See annotated Fig. 4C below, which indicates the pointed tips of the cells. Since Gross discloses the inductor coils being disposed along the struts outlining the cells, it is obvious that it includes the pointed tips (Gross, Fig. 14C; Page 84, line 29 – Page 85, line 4: “Fig. 14C shows a prosthetic aortic valve 820C. In this configuration, prosthetic- valve coil 836 is a first prosthetic-valve coil 836C, the plurality of stent struts 831 is a first plurality of stent struts 831, and plurality 835 of stent cells 833 is a first plurality 835C of stent cells 833. Prosthetic aortic valve 820 further comprises a second prosthetic-valve coil 836D, which is in non-wireless electrical communication with cathode 54 and anode 57, and is coupled to a second plurality of stent struts 831, running along stent struts 831 so as to surround a second plurality 835D of stent cells 833”)); and the second inductor coil is removably attached to the pointed tips of each of the second subset of the plurality of cells by a second plurality of sutures (Braido, [0042]: “Sensors may also be disposed on either the inner diameter, the outer diameter or a combination of both and may be sutured, glued, welded, or made integral with the stent”; [0035]: “nitinol loops 310 may be removed and replaced with suture holes for attachment, and cantilevers or other structural members may be added”. The inductor coils are part of the sensors, therefore can be sutured as the attachment mechanism).
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Regarding claim 10, the Braido/Gross combination teaches the prosthetic valve of claim 2, wherein the frame is formed from a biocompatible metallic material (Braido, [0023]: “Prosthetic heart valve 100 (FIG. 1) includes expandable stent 102 which may be formed from biocompatible materials that are capable of self-expansion, such as, for example, shape memory alloys, such as the nickel-titanium alloy known as “Nitinol” or other suitable metals or polymers”).
Regarding claim 11, the Braido/Gross combination teaches the prosthetic valve of claim 2.
However, the Braido/Gross combination is silent on the material of the inductor coils.
Gross teaches wherein each of the first and second inductor coils are formed from gold.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the material of the coils from Gross as the Braido/Gross combination is silent on the material of the coils, and Gross discloses a suitable material in an analogous device.
Regarding claim 12, the Braido/Gross combination teaches the prosthetic valve of claim 2, wherein each of the first and second sensors are capacitive pressure sensors, and wherein the sensed physical parameter is pressure (Braido, [0031]: “Sensor 300 generally includes body 302 formed of a generally hollow fused silica housing 301 with a silicone coating around the exterior of the housing. An elongated boss 305, also formed from fused silica, may project into the interior of housing 301 and may be formed integrally therewith. A plurality of electrically conductive windings may wrap around boss 305 to form an inductor coil 304. Capacitive plates 306 and 307 are separated by micrometer spacing, forming a variable capacitor. Capacitive plate 306 is sensitive to pressure and experiences nanometer scale deflections due to changes in blood pressure acting on the sensor 300”).
Regarding claim 13, the Braido/Gross combination teaches the prosthetic valve of claim 2, wherein the first circuit has first self-resonant frequency, and wherein the second circuit has a second self- resonant frequency, the second self-resonant frequency being different from the first self-resonant frequency (Braido, [0032]: “The sensor 300 can be electromagnetically coupled to a transmitting antenna (not shown). Consequently, a current is induced in the sensor 300, which oscillates at the resonant frequency of the circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 307. This oscillation causes a change in the frequency spectrum of the transmitted signal. From this change, the bandwidth and resonant frequency of the particular sensor may be determined, from which the corresponding blood pressure can be calculated”; [0034]: “Sensor 300 may be modified for various applications and tuned to selectively emphasize different parameters. For example, by varying the width of the windings of inductor coil 304, the number of turns and the gap between the upper and lower windings, the resonant frequency that the device operates at and the pressure sensitivity (i.e., the change in frequency as a result of membrane deflection) can be optimized for different applications”; [0035]: “The thickness of sensor 300 may also be varied to alter mechanical properties”; [0042]: “As illustrated, a first group of sensors 450C are disposed in annulus section 440 adjacent the proximal end 402 of stent 410, while a second group of sensors 450C′ are disposed in aortic section 444 adjacent the distal end 404 of the stent. The first group of sensors 450C may be configured to monitor one or more parameters at the inflow end of heart valve 400C, while the second group of sensors 450C′ may be configured to monitor one or more parameters at the outflow end of heart valve 400C. Any number of sensors may be used in either the first or second group of sensors”. Changing the thickness of the sensor can change the self resonant frequency, therefore sensors 450C and 450C’ can have different self resonant frequencies by having different thicknesses.).
However, the Braido/Gross combination is silent on the specific frequency range.
Gross teaches the self-resonant frequency ranging from 5 MHz to 50 MHz (Page 70, lines 17-22: “External-unit control circuitry 104 (shown in Fig. 10D) typically wirelessly transfers energy to prosthetic-valve coil 336 by generating a plurality of AC pulses, each AC pulse including a train of AC bursts. The train of AC bursts may be generated, for example, at a frequency of between 3 kHz and 130 kHz (e.g., between 3 kHz and 100 kHz, or between 100 kHz and 130 kHz), or a frequency of between 12 and 20 MHz, such as between 13 and 20 MHz, e.g., 13.56 MHz, for improved efficiency”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the frequency range from Gross in the Braido/Gross combination as the combination is silent on the specific range, and Gross discloses a suitable range in an analogous device.
Regarding claim 17, the Braido/Gross combination teaches a monitoring system comprising: a prosthetic valve assembly (Braido, Abstract: “A prosthetic device for implanting in a patient's heart includes (i) a therapeutic device capable of restoring function to a native heart valve; and (ii) at least one sensor including a body, an inductor coil disposed within the body, and a capacitor in communication with the inductor coil, the at least one sensor being coupled to the therapeutic device, and being configured to monitor proper function of the therapeutic device within the patient's heart.”) comprising: the prosthetic valve of claim 2 (see rejection of claim 2 above): a transmitter in communication with the first sensor and the second sensor (Braido, [0032]: “The sensor 300 can be electromagnetically coupled to a transmitting antenna (not shown)”. The transmitting antenna is the transmitter); an external device in communication with the prosthetic valve assembly; wherein the external device comprises a transceiver in wireless communication with the prosthetic heart valve assembly (Braido, [0057]: “A processor 704 is included to obtain data from the sensors relating to force, pressure or elasticity measured by each of the sensors. Any processor can be used and can be as simple as an electronic device that, for example, is capable of receiving and interpreting instructions from an external programming unit 708 and performing calculations based on the various algorithms described above … data relating to valve diagnosis may be sent from programming unit 708 to processor 704 and the processor may determine the appropriate course of action or alert a clinician. Communication between programming unit 708 and processor 704 may be accomplished via communication of antenna 718 with telemetry unit 706”. The external programming unit is the external device, which includes a transceiver to be able to receive the data.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Braido/Gross combination as applied to claim 3 above, and further in view of Pool (US 20220323012).
Regarding claim 4, the Braido/Gross combination teaches the prosthetic valve of claim 3.
However, the Braido/Gross combination does not teach wherein: the first post assembly comprises a first post and a first islet; the second post assembly comprises a second post and a second islet; the first sensor is mounted to the first islet; and the second sensor is mounted to the second islet.
Pool discloses sensor integration in cardiac implant devices. Specifically, Pool teaches wherein: the first post assembly comprises a first post and a first islet; the second post assembly comprises a second post and a second islet; the first sensor is mounted to the first islet; and the second sensor is mounted to the second islet ([0177]: “FIGS. 12A and 12B show perspective views of a medical implant device including a sensor-support structure or assembly 120 including a sensor-support strut/arm and a membrane sock- or wrap-type retention means or feature 123 configured to at least partially secure a sensor device to the sensor-support strut/arm”. It is obvious that if one post assembly has the post and islet, the other one has it as well, therefore this structure is on both the first post assembly and the second post assembly, (See annotated sensor structure below)). Braido, Gross, and Pool are analogous art as they are all related to the same field of endeavor of devices implanted into the heart of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the post and islet from Pool into the Braido/Gross combination as the combination is silent on the specific structure of the post assemblies, and Pool discloses a suitable structure in an analogous device.
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Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over the Braido/Gross combination as applied to claim 2 above, and further in view of Maginess (EP 2859911).
Regarding claim 5, the Braido/Gross combination teaches the prosthetic valve of claim 2.
However, the Braido/Gross combination does not teach further comprising: a first detuning mitigation layer disposed between the first inductor coil and the frame; and a second detuning mitigation layer disposed between the second inductor coil and the frame.
Maginess discloses vascular access port devices with incorporated sensors. Specifically, Maginess teaches further comprising: a first detuning mitigation layer disposed between the first inductor coil and the frame ([0030]: “The inductive coil element may be located in an upper portion of the cartridge cavity around an inner wall thereof, In one embodiment, a liner, preferably made from a high magnetic permeability ferrite material to increase coil inductance and coupling to external readout devices”. The ferrite liner is the detuning mitigation layer, and since it is a liner, it can be located between the coil and the frame.); and a second detuning mitigation layer disposed between the second inductor coil and the frame ([0030]: “The inductive coil element may be located in an upper portion of the cartridge cavity around an inner wall thereof, In one embodiment, a liner, preferably made from a high magnetic permeability ferrite material to increase coil inductance and coupling to external readout devices”. The inductive coil used in the second sensor can also have the same structure, including the second detuning mitigation layer.). Braido, Gross, and Maginess are analogous art as they are all related to the same field of endeavor of devices implanted into the heart of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detuning mitigation layers from Maginess into the Braido/Gross combination as it can prevent an unintended shift of the resonant frequency and ensure the device is recording the correct values, improving the accuracy of the device.
Regarding claim 6, the Braido/Gross/Maginess combination teaches the prosthetic heart valve of claim 5, wherein each of the first and second detuning mitigation layers comprise ferrite (Maginess, [0030]: “The inductive coil element may be located in an upper portion of the cartridge cavity around an inner wall thereof, In one embodiment, a liner, preferably made from a high magnetic permeability ferrite material to increase coil inductance and coupling to external readout devices”).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over the Braido/Gross/Maginess combination as applied to claim 6 above, and further in view of Sweeney (US 20210038094).
Regarding claim 7, the Braido/Gross/Maginess combination teaches the prosthetic heart valve of claim 6.
However, the Braido/Gross/Maginess combination does not teach further comprising: a first insulating layer surrounding the first detuning mitigation layer and the first inductor coil; and a second insulating layer surrounding the second detuning mitigation layer and the second inductor coil.
Sweeney discloses vascular monitoring devices including stents. Specifically, Sweeney teaches further comprising: a first insulating layer surrounding the first detuning mitigation layer and the first inductor coil ([0009]: “collapsible variable inductance coil with the plurality of wire strands … an outer insulating layer covering the plurality of wires”. The detuning mitigation layers are included in the structure of the coil, therefore are surrounded by the outer insulating layer.); and a second insulating layer surrounding the second detuning mitigation layer and the second inductor coil ([0009]: “collapsible variable inductance coil with the plurality of wire strands … an outer insulating layer covering the plurality of wires” The inductive coil used in the second sensor can also have the same structure, including the second insulating layer.). Braido, Gross, Maginess, and Sweeney are analogous art as they are all related to the same field of endeavor of devices implanted into the heart of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the insulating layers from Sweeney into the Braido/Gross/Maginess combination as it ensures that the currents remain entirely contained within the correct structures and allows for a protective layers that ensures the coil is protected and does not become damaged due to bodily fluids.
Regarding claim 8, the Braido/Gross/Maginess/Sweeney combination teaches the prosthetic heart valve of claim 7.
However, the Braido/Gross/Maginess/Sweeney combination is silent on the material of the insulating layers.
Sweeney teaches wherein the first and second insulating layers comprise one of silicone, parylene, and polyimide ([0082]: “20 turns of 15 strands of wire are used along with an outer insulation layer 60 of silicone”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the material of the insulating layers from Sweeney into the Braido/Gross/Maginess/Sweeney combination as the combination is silent on the material of the insulating layers, and Sweeney discloses a suitable material in an analogous device.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over the Braido/Gross combination as applied to claim 2 above, and further in view of Marquez (US 20170258585).
Regarding claim 14, the Braido/Gross combination teaches the prosthetic valve of claim 2.
However, the Braido/Gross combination does not teach wherein the frame is at least partially covered with a first biocompatible fabric, the first biocompatible fabric being disposed between at least a portion of the first inductor coil or the second inductor coil and the frame.
Marquez discloses a valve implant. Specifically, Marquez teaches wherein the frame is at least partially covered with a first biocompatible fabric, the first biocompatible fabric being disposed between at least a portion of the first inductor coil or the second inductor coil and the frame ([0133]: “The valve assembly 410 includes a frame member 492, which can comprise a metal/wireform frame structure. In certain embodiments, the frame member 492 can be at least partially covered with fabric or other material”; [0137]: “The sealing ring 491 can comprise an inner at least partially rigid substrate (e.g., metal such as stainless or titanium, or a flexible material such as silicone rubber or PET (e.g., DACRON PET) cordage), and can be at least partially covered with a biocompatible fabric or cloth to allow the ring to be sutured to the heart tissue.” The part of the frame covered can be a portion between the frame and the inductor coil.). Braido, Gross, and Marquez are analogous art as they are all related to the same field of endeavor of prosthetic heart valves.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fabric from Marquez into the Braido/Gross combination as it allows the device to be sutured to the heart tissue, which can provide a strong connection point into the body of the user.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over the Braido/Gross/Marquez combination as applied to claim 14 above, and further in view of Tayeb (US 20190000615).
Regarding claim 15, the Braido/Gross/Marquez combination teaches the prosthetic valve of claim 14.
However, the Braido/Gross/Marquez combination does not teach wherein a second biocompatible fabric covers at least one of the first inductor coil or the second inductor coil.
Tayeb discloses a docking station for transcatheter valves. Specifically, Tayeb teaches wherein a second biocompatible fabric covers at least one of the first inductor coil or the second inductor coil ([0252]: “A covering/material (not shown), such as one of the coverings/materials described elsewhere herein, a cloth, fabric, or a protective foam can be provided inside or outside the coil to provide a sealing portion to the coil 5100”; [0225]: “A variety of biocompatible covering materials can be used such as any materials described elsewhere herein, including foam or a fabric that is treated with a coating that is impermeable to blood, polyester, or a processed biological material, such as pericardium.”). Braido, Gross, Marquez, and Tayeb are analogous art as they are all related to the same field of endeavor of prosthetic heart valves.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the fabric covering the coil from Tayeb into the Braido/Gross/Marquez combination as it allows for a suitable connection portion on the coils.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over the Braido/Gross combination as applied to claim 2 above, and further in view of Orlov (US 20200046491).
Regarding claim 16, the Braido/Gross combination teaches the prosthetic valve of claim 2.
However, the Braido/Gross combination does not teach wherein the prosthetic valve is sterilized.
Orlov discloses a method for deploying a prosthetic valve. Specifically, Orlov teaches wherein the prosthetic valve is sterilized ([0170]: “the empty volume of delivery lumen 78 is filled with a sterile preservative solution (e.g., glutaraldehyde solution) to maintain the valve mechanism of prosthetic mitral valve 50 sterile and ready for use”). Braido, Gross, and Orlov are analogous art as they are all related to the same field of endeavor of prosthetic heart valves.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the valve being sterilized from Orlov into the Braido/Gross combination as it ensures the valve is clean and safe for implantation into the user.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Braido in view of Felix (US 20210000345) and Maginess.
Regarding independent claim 18, Braido teaches a prosthetic valve ([0002]: “The present invention relates to heart valve replacement”) comprising:
a flexible frame disposed along a frame axis (Stent 410 is a frame disposed along a frame axis (the top-to-bottom axis of the stent)) and deformable about the frame axis between a crimped state and an expanded state ([0005]: “Collapsible prosthetic heart valves typically take the form of a valve structure mounted on a stent. There are two types of stents on which the valve structures are ordinarily mounted: a self-expanding stent and a balloon-expandable stent. To place such valves into a delivery apparatus and ultimately into a patient, the valve must first be collapsed or crimped to reduce its circumferential size”. The collapsed state is the crimped state, and the regular state is the expanded state.), the frame comprising:
a first end (Distal end 404);
a second end oppositely disposed from the first end (Proximal end 402);
a network of interconnected struts defining a plurality of cells ([0038]: “Stent 410 may include a plurality of struts 412 forming a plurality of cells 414”);
a multilayer sensing assembly mounted on the frame ([0031]: “FIGS. 3A and 3B illustrate one example of a sensor for diagnostic usage … Capacitive plate 306 is sensitive to pressure and experiences nanometer scale deflections due to changes in blood pressure acting on the sensor 300. These nanometer scale deflections result in a change in the resonant frequency of circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 30”; [0035]: “The thickness of sensor 300 may also be varied to alter mechanical properties. Thicker substrates for forming housing 301 are more durable for manufacturing. Thinner substrates allow for creation of thin pressure sensitive membranes for added sensitivity. In order to optimize both properties, sensor 300 may be manufactured using two complementary substrates of different thicknesses. For example, one side of sensor 300 may be constructed from a substrate having a thickness of about 200 microns. This provides the ability to develop and tune sensors based on the operational environment of the implanted sensor 300 In addition to changes to housing 301, other modifications may be made to the sensor depending on the application”; [0064]: “It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments”. The sensor 300 can be used as the sensors 450C’ in Fig. 4C shown on the stent 410.), the multilayer sensing assembly comprising:
a first inductor coil disposed on a substrate ([0032]: “The sensor 300 can be electromagnetically coupled to a transmitting antenna (not shown). Consequently, a current is induced in the sensor 300, which oscillates at the resonant frequency of the circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 307’”; [0035]: “The thickness of sensor 300 may also be varied to alter mechanical properties. Thicker substrates for forming housing 301 are more durable for manufacturing. Thinner substrates allow for creation of thin pressure sensitive membranes for added sensitivity. In order to optimize both properties, sensor 300 may be manufactured using two complementary substrates of different thicknesses. For example, one side of sensor 300 may be constructed from a substrate having a thickness of about 200 microns. This provides the ability to develop and tune sensors based on the operational environment of the implanted sensor 300 In addition to changes to housing 301, other modifications may be made to the sensor depending on the application”).
However, Braido does not teach the first inductor coil including a pair comprising first upper and lower inductor coil portions, the first inductor coil pair disposed on a flexible substrate.
Felix discloses an implantable medical device that can be used to monitor the heart. Specifically, Felix teaches the first inductor coil including a pair comprising first upper and lower inductor coil portions ([0059]: “the foldable (or rollable) area 33 is defined to form, when installed inside the IMD 10, a diagonal antenna that (not shown) will limit dead zones by creating a spiral where the two halves of the receiving coil connect”. The two halves of the receiving coil are the upper and lower inductor coil portions), the first inductor coil pair disposed on a flexible substrate ([0054]: “The flexible circuit board 30 is formed out of a single piece of flexible circuit board substrate defining a flexible circuit board 30 for placement of the microcontroller and device circuitry, a pair of vertically disposed foldable “ears” 32 provided on opposite ends of the flexible circuit board 30, and a foldable (or rollable) area 33 that acts as a receiving coil for inductive power coupling”). Braido and Felix are analogous art as they are both related to the same field of endeavor of devices implanted to monitor the heart of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure of the coil from Felix into the device from Braido as the combination is silent on the specific structure of the coil, and Felix discloses a detailed structure of the coil in an analogous device.
However, the Braido/Felix combination does not teach a detuning mitigation layer disposed between the frame and the flexible substrate.
Maginess teaches a detuning mitigation layer disposed between the frame and the flexible substrate ([0030]: “The inductive coil element may be located in an upper portion of the cartridge cavity around an inner wall thereof, In one embodiment, a liner, preferably made from a high magnetic permeability ferrite material to increase coil inductance and coupling to external readout devices”. The ferrite liner is the detuning mitigation layer, and since it is a liner, it can be located between the coil and the frame.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detuning mitigation layers from Maginess into the Braido/Felix combination as it can prevent an unintended shift of the resonant frequency and ensure the device is recording the correct values, improving the accuracy of the device.
The Braido/Felix/Maginess combination teaches a first sensor in electrical communication with the first inductor coil pair (Braido, Sensors 450C’);
wherein the first sensor is configured to sense a physical parameter (Braido, [0036]: “Sensors 300 may be used to measure one or more parameters including real time blood pressure, flow velocity (e.g., blood flow), apposition forces based on pressure changes due to interaction between two surfaces of the prosthetic valve, impingement forces, which are correlated to pressure changes caused by the interaction between a surface of the prosthetic device and native tissue, cardiac output, effective orifice area, pressure drop, and aortic regurgitation. Sensor 300 provides time-resolved pressure data which may be correlated to the parameters of interest based on empirical correlations that have been presented in literature. In some examples, sensors 300 may function similar to piezo-electric strain gauges to directly measure a parameter. Other parameters may be indirectly calculated. One specific method of using sensors 300 to measure aortic regurgitation”) and generate a signal representing the physical parameter (Braido, [0032]: “The sensor 300 can be electromagnetically coupled to a transmitting antenna (not shown). Consequently, a current is induced in the sensor 300, which oscillates at the resonant frequency of the circuit formed by the inductor coil 304 and pressure-sensitive capacitor formed by plated 306 and 307. This oscillation causes a change in the frequency spectrum of the transmitted signal. From this change, the bandwidth and resonant frequency of the particular sensor may be determined, from which the corresponding blood pressure can be calculated. Time-resolved blood pressure measurements can be correlated to flow using empirical relationships established in clinical literature”. The transmitted signal is the signal.).
Regarding claim 19, the Braido/Felix/Maginess combination teaches the prosthetic valve of claim 18.
However, the Braido/Felix/Maginess combination does not teach further comprising: an insulating layer encapsulating the detuning mitigation layer and the flexible substrate.
Felix teaches further comprising: an insulating layer encapsulating the detuning mitigation layer and the flexible substrate ([0054]: “The flexible circuit board 30 can include circuit traces on all sides, or multiple layers covered by an insulating layers to maximize space utilization”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the insulating layers from Felix into the Braido/Felix/Maginess combination as it ensures that the currents remain entirely contained within the correct structures and allows for a protective layers that ensures the coil is protected and does not become damaged due to bodily fluids.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over the Braido/Felix/Maginess combination as applied to claim 18 above, and further in view of Pool.
Regarding claim 20, the Braido/Felix/Maginess combination teaches the prosthetic valve of claim 18.
However, the Braido/Felix/Maginess combination does not teach further comprising: a first soft magnetic layer disposed on the flexible substrate between the first upper and lower inductor coil portions.
Pool teaches further comprising: a first soft magnetic layer disposed on the flexible substrate between the first upper and lower inductor coil portions ([0253]: “The one or more magnets 453 may be configured to function as sensor-retention magnet(s), wherein a corresponding magnetic element 455 associated with a sensor device 454 may be attracted to the one or more magnets 453, thereby at least partially securing and/or positioning the sensor device 454 when the magnet(s) of the structure 450 and the corresponding magnet(s) of the sensor 454 are disposed in proximity to one another, as shown”; [0254]: “The sensor magnet 455 may be internal to the cylinder (e.g., glass cylinder) of the sensor 454”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the magnetic layer from Pool into the Braido/Felix/Maginess combination as it allows the sensor portion to have a simple and easy connection point.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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