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 .
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, 4-6, 8-9, 11-16, 29-30, 32-34 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks; Cornelis Petrus et al. (US 20200321808 A1, published earlier as WO 2019063742 A1) in view of Shaolian; Samuel M. et al. (US 20110218622 A1).
Regarding claim 1, Hendriks discloses an implantable medical device (¶ [0020], the wirelessly controllable device may be an implantable device; ¶ [0079], implantable devices; ¶ [0083], FIG. 3, which shows a system 30 … including a wirelessly controllable device 20 … are in the form of an implantable device; ¶ [0081], envisioned functions include for example blood flow restriction, stent delivery, acoustic antifouling, and controlled drug delivery);
the device comprising: an actuation element (¶ [0085] The remotely controllable device comprises a plurality of actuator elements 22a, 22b, 22c);
composed of a shape memory material and having a preferred geometry, wherein, when the actuation element is deformed relative to its preferred geometry and is heated above a transition temperature, the actuation element is configured to move toward its preferred geometry (¶ [0091] The actuator elements 22 in the example of FIG. 3 each comprise a responsive material deformable in response to an electrical stimulus … In further examples, the actuator element may comprise a different responsive material, for instance a smart memory alloy, deformable by thermal stimulation; ¶ [0143], Other responsive materials include, by way of example, heat-responsive shape-memory materials, such as shape-memory alloys and shape memory polymers (stimulated for instance by joule heating)); and
an inductor configured to generate a current when exposed to an electromagnetic field (¶ [0085], a respective receiver circuit 24a, 24b, 24c for electrically supplying the actuator element);
wherein the inductor forms a resonant circuit that includes the actuation element (¶ [0087] The inductance of the inductive coil 26 and capacitance of the capacitor 27 are selected for each receiver circuit such that each receiver circuit is ‘tuned’ to have a different characteristic resonant frequency); and
wherein the resonant circuit is configured such that current flows through and resistively heats the actuation element when the inductor generates the current (¶ [0091] The actuator elements 22 in the example of FIG. 3 each comprise a responsive material deformable in response to an electrical stimulus … In further examples, the actuator element may comprise a different responsive material, for instance a smart memory alloy, deformable by thermal stimulation, induced for instance by joule heating of the actuator element 22 through application of an electrical current);
wherein the actuation element has a first surface area, and wherein the inductor has a second surface area (Figs. 5, 6, actuator elements 22a, 22b, 22c, and inductive coils 26a, 26b, 26c each represent physical components and therefore have surface areas).
Hendriks teaches both an actuation element and an inductor but not in a single embodiment. A skilled artisan would have been able to modify Hendriks by constructing actuator elements 22a, 22b, 22c from a smart memory alloy or shape-memory alloy according to ¶ [0091], [0143]. One would be motivated to modify Hendriks’s actuation elements with a shape-memory alloy since Hendriks describes this as a useful alternative.
Also, Hendriks calls for constructing an implantable shunt (¶ [0022] The device may for example be … a restenosis sensor (e.g. iStent); ¶ [0081], restenosis sensors (iStent) … blood flow restriction, stent delivery; ¶ [0140] stents with adaptive restriction which varies over their length (e.g. to adapt pressure or flow rate)). The shape-memory alloy known as NiTi, nickel-titanium or Nitinol is biocompatible and widely used for constructing implantable shunts. Therefore, it would have been obvious to modify Hendriks’s implant with a shape-memory alloy in order to construct a stent with a well-known material.
Hendriks is silent whether the inductor has a second surface area greater than the first surface area of the actuation element. Shaolian discloses a dynamically adjustable annuloplasty ring constituting an implantable medical device (¶ [0002], [0017], [0018] FIG. 1A illustrates circuitry of an implantable dynamically adjustable annuloplasty ring assembly 102);
comprising: an actuation element composed of a shape memory material and having a preferred geometry (¶ [0017], A dynamically adjustable annuloplasty ring may include, for example, shape memory material such as Nitinol; ¶ [0019], annuloplasty ring 210);
an inductor configured to generate a current when exposed to an electromagnetic field, wherein the inductor forms a resonant circuit that includes the actuation element (¶ [0019], The implantable dynamically adjustable annuloplasty ring assembly 102 comprises a second (receiving) coil 114, positioned within the patient, that is designed to resonate at substantially the same frequency as that of the delivery coil 112 connected to the power source 110); and
wherein the resonant circuit is configured such that current flows through and resistively heats the actuation element when the inductor generates the current (¶ [0019], To activate the annuloplasty ring 210, the delivery coil 112 is placed near the receiving coil 114 of the annuloplasty ring 210 (e.g., near the patient's chest) and switched on. Power from the resonating magnetic field 212 (shown in FIG. 2) is then inductively transferred across the skin barrier to the receiving coil 114 and converted to electrical current that is subsequently used to heat the annuloplasty ring 210);
PNG
media_image1.png
470
836
media_image1.png
Greyscale
wherein the actuation element has a first surface area, and wherein the inductor has a second surface area greater than the first surface area (Fig. 1A, second coil 114 has 15 turns to provide 10.4 µH of inductance while heating element 116 (R1) appears as a 100 Ω ring; Fig. 2, second (receiving) coil 114 has a larger diameter and more coils than heating element 116).
Shaolian demonstrates how to construct an inductively powered system where a receiver coil receives energy and serves as a power source, and delivers the energy to a power sink. Shaolian shows that a receiver coil should contain multiple turns in order to receive RF energy from a tuned transmitter coil. In general, configuring an inductor with additional turns or windings increases its inductance and ability to send or receive energy. One would be motivated to modify Hendriks with Shaolian’s relatively larger inductor surface so that the inductor can generate adequate current through the RLC circuit. A skilled artisan would have been able to modify Hendriks with Shaolian’s relatively larger inductor surface by configuring Hendriks’s inductor(s) with more turns or larger dimensions than the actuator element(s). Therefore, it would have been obvious to modify Hendriks with Shaolian in order to generate and deliver adequate electric current to the actuator element.
Regarding claim 29, Hendriks discloses a method for controlling a medical device implanted in a patient (¶ [0043], a method of wirelessly controlling a device; claim 15. A method of wirelessly controlling a device);
the method comprising: directing energy (¶ [0097] The control unit 28 comprises a transmitter coil arrangement 32 operable to generate a magnetic field for supplying electrical energy to the receiver circuits 24 of the wirelessly controllable device 20 through inductive coupling; ¶ [0098] A controller 36 is operatively coupled with the transmitter coil arrangement 32, for controlling generation by means of the coil arrangement of an oscillatory magnetic field);
toward an inductor implanted in the patient (¶ [0085], Each of the receiver circuits comprises a respective inductive coil 26a, 26b, 26c for receiving electrical energy (from the control unit 28) by inductive coupling);
wherein the inductor forms a resonant circuit (¶ [0087] The inductance of the inductive coil 26 and capacitance of the capacitor 27 are selected for each receiver circuit such that each receiver circuit is ‘tuned’ to have a different characteristic resonant frequency);
that includes an actuation element of the implanted medical device (¶ [0085] The remotely controllable device comprises a plurality of actuator elements 22a, 22b, 22c); and
wherein the actuation element is composed of a shape memory material and is deformed relative to a preferred geometry of the actuation element, and in response to the energy, automatically generating a current in the inductor (¶ [0085], a respective receiver circuit 24a, 24b, 24c for electrically supplying the actuator element);
wherein the current flows through and resistively heats the actuation element above a transition temperature to move the actuation element toward the preferred geometry (¶ [0091] The actuator elements 22 in the example of FIG. 3 each comprise a responsive material deformable in response to an electrical stimulus … In further examples, the actuator element may comprise a different responsive material, for instance a smart memory alloy, deformable by thermal stimulation; ¶ [0143], Other responsive materials include, by way of example, heat-responsive shape-memory materials, such as shape-memory alloys and shape memory polymers (stimulated for instance by joule heating)).
This rejection combines Hendriks’s embodiments to construct a stent from a shape-memory alloy. Regarding the rationale and motivation to modify Hendriks’s embodiments, see the discussion of claim 1 above.
Hendriks does not explicitly disclose that the inductor has a greater surface area than the actuation element. Shaolian discloses an adjustable annuloplasty ring wherein an actuation element has a first surface area, and wherein an inductor has a second surface area greater than the first surface area (Fig. 1A, second coil 114 has 15 turns to provide 10.4 µH of inductance while heating element 116 (R1) appears as a 100 Ω ring; Fig. 2, second (receiving) coil 114 has a larger diameter and more coils than heating element 116).
Shaolian configures an inductor to generate adequate current through an RLC circuit. Regarding the rationale and motivation to modify Hendriks with Shaolian’s relatively larger inductor, see the discussion of claim 1 above.
Regarding claims 2, 4-5, 11, 13, 15, 30, 32-34 and 36-37, Hendriks discloses that the inductor is configured to generate a current when exposed to an electromagnetic field generated by an energy source positioned external to the patient (¶ [0085], a respective receiver circuit 24a, 24b, 24c for electrically supplying the actuator element; ¶ [0091], In further examples, the actuator element may comprise a different responsive material, for instance a smart memory alloy, deformable by thermal stimulation, induced for instance by joule heating of the actuator element 22 through application of an electrical current; ¶ [0098] A controller 36 is operatively coupled with the transmitter coil arrangement 32 … The transmitter coil arrangement comprises one or more inductive coils for supplying electrical energy to the receiver circuits 24 via inductive coupling);
wherein directing the energy toward the inductor includes generating an electromagnetic field around the inductor (¶ [0097] The control unit 28 comprises a transmitter coil arrangement 32 operable to generate a magnetic field for supplying electrical energy to the receiver circuits 24 of the wirelessly controllable device 20 through inductive coupling);
wherein the inductor is configured to generate a current in response to delivery of radiofrequency (RF) and/or microwave energy (¶ [0097] The control unit 28 comprises a transmitter coil arrangement 32 operable to generate a magnetic field for supplying electrical energy to the receiver circuits 24 of the wirelessly controllable device 20 through inductive coupling);
wherein the resonant circuit is an RLC circuit (¶ [0013] The resonance frequency of each receiver circuit is a function of both an inductance of the inductive receiver coil and a capacitance of the capacitor; ¶ [0129] As illustrated, a diode 31 is provided within each receiver circuit, connected in series between the actuator element 22 and the capacitor 27 (and inductive coil 26));
wherein the resonant circuit is configured to dissipate power as the current flows through the actuation element (Hendriks describes an electrical circuit comprising a diode 31, actuator element 22, capacitor 27 and inductive coil 26. Every electrical circuit will inherently dissipate power when current flows through it);
wherein the actuation element is in series with the inductor (Figs. 3 and 5 show two variants of circuits where the actuator elements 22a-22c are in series with an inductor, capacitor and an optional diode);
wherein, when implanted in a human patient, the device is configured to shunt fluid between a first body region and a second body region (¶ [0022] The device may for example be or include a blood pressure sensor (Cardiomems), a restenosis sensor (e.g. iStent), or device for facilitating controlled drug delivery, such as for instance a micro-peristaltic pump (MPS microsystems); ¶ [0081], restenosis sensors (iStent), or actuators for controlled drug delivery, such as micro-peristaltic pumps (MPS microsystems). With regards more active functionality, envisioned functions include for example blood flow restriction, stent delivery, acoustic antifouling, and controlled drug delivery);
wherein the transition temperature is a temperature greater than body temperature (¶ [0091] The actuator elements 22 in the example of FIG. 3 each comprise a responsive material deformable in response to an electrical stimulus … In further examples, the actuator element may comprise a different responsive material, for instance a smart memory alloy, deformable by thermal stimulation; ¶ [0143], Other responsive materials include, by way of example, heat-responsive shape-memory materials, such as shape-memory alloys and shape memory polymers (stimulated for instance by joule heating));
wherein heating the actuation element above the transition temperature transforms the actuation element from a first configuration in which it is deformed relative to a preferred geometry to and/or toward a second configuration in which it assumes its preferred geometry; wherein moving the actuation element from the first configuration toward the second configuration controls one or more operations of the implanted medical device (¶ [0091], the actuator element may comprise a different responsive material, for instance a smart memory alloy, deformable by thermal stimulation, induced for instance by joule heating of the actuator element 22 through application of an electrical current);
wherein the implanted medical device is a shunt fluidly connecting a first body region and a second body region (¶ [0022] The device may for example be … a restenosis sensor (e.g. iStent); ¶ [0081], restenosis sensors (iStent) … blood flow restriction, stent delivery; ¶ [0140] stents with adaptive restriction which varies over their length (e.g. to adapt pressure or flow rate)).
Regarding the transition temperature above body temperature, Hendriks controls the implant with resistive or joule heating (¶ [0091]). In order for the implant to respond specifically to joule heating, the transition temperature must necessarily be greater than body temperature. Otherwise, the implant will change shape when its temperature equilibrates with surrounding tissues instead of responding to Hendriks’s inductive circuit.
Regarding claim 6, Hendriks does not explicitly disclose the relative resistance values of the actuation element and the inductor.
The resistance ratio is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The resistance ratio determines how much power is dissipated by each of the actuation element and electrical components through routine experimentation. For example, an excessively high source resistance (the inductor) will not efficiently transfer energy to the load (the actuation element). Therefore, it would have been obvious to adjust the resistance ratio in order to efficiently deliver power to the actuation element. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 8 and 9, Hendriks is silent whether the actuation element’s power dissipation density is greater than the inductor’s, or whether the inductor is longer than the actuation element. Shaolian discloses a dynamically adjustable annuloplasty ring constituting an implantable medical device (¶ [0002], [0017], [0018] FIG. 1A … ring assembly 102);
wherein, when current flows through the inductor and the actuation element, a first power dissipation density in the actuation element is greater than a second power dissipation density in the inductor by virtue of the second surface area being greater than the first surface area (annotated Fig. 2 shows that the inductor has a larger area than the actuator; therefore when an equal amount of power travels through each component, the actuator will dissipate power at a greater density);
wherein the actuation element has a first length, and wherein the inductor has a second length greater than the first length (Fig. 1A, second coil 114 has 15 turns to provide 10.4 µH of inductance while heating element 116 (R1) appears as a 100 Ω ring; therefore the second (receiving) coil 114 has a longer length).
Shaolian configures a receiver coil to receive adequate power from a transmitter coil by sizing the receiver relatively larger than a power sink or actuator. Regarding the rationale and motivation to modify Hendriks with Shaolian’s relatively larger inductor, see the discussion of claim 1 above.
Regarding claim 12, Hendriks is silent regarding the resonant circuit’s quality factor.
The quality factor is interpreted as a result-effective variable, subject to experimentation and testing. The quality factor relates to a resonator’s resonance width according to the equation
Q
≝
f
r
∆
f
where Q = quality factor; fr = resonance frequency; Δf = resonance width.
Selecting a quality factor of less than 100 will provide a reasonably narrow resonance width.
Hendriks calls for distinguishing at least three resonators by tuning them to different frequencies (¶ [0012] The resonance frequency of each receiver circuit is tuned to a different respective frequency; ¶ [0088] Each circuit may, in examples, be tuned to a desired resonant frequency) and also calls for a narrow tolerance for resonance width (¶ [0122] By way of example, an applied frequency component may be varied in its frequency within a range of approximately +/−4-5% of the resonant frequency of the receiver circuit, or alternatively within a range approximately +/−2-3% or within a range approximately +/−1-2). Therefore it would have been obvious to select a quality factor of less than 100 in order to achieve a desired tolerance for the resonance frequency.
Regarding claim 14, Hendriks is silent regarding the composition of the shape memory material. Shaolian discloses that the shape memory material includes an alloy comprising one or more of nickel, titanium, and copper (¶ [0017] A dynamically adjustable annuloplasty ring may include, for example, shape memory material such as Nitinol).
Shaolian selects a well-known shape memory alloy that is biocompatible and can be obtained commercially. One would be motivated to modify Hendriks with Shaolian’s Nitinol to construct a biocompatible implant suitable for being implanted. Therefore, it would have been obvious to modify Hendriks with Shaolian’s Nitinol in order to construct the implant from an easily obtained and biocompatible material.
Regarding claim 16, further describes a shunting element having a lumen extending therethrough and configured such that, when the shunting element is implanted in the patient, the lumen fluidly connects the first body region and the second body region (¶ [0135] Particular implantable device applications for which the present invention is suitable include: ¶ [0137] shape adaptation of stent grafts after their placement in order to prevent leakage; ¶ [0140] stents with adaptive restriction which varies over their length);
wherein the actuation element is configured to adjust a geometry of the lumen (¶ [0140] stents with adaptive restriction which varies over their length (e.g. to adapt pressure or flow rate).
Although Hendriks does not depict a lumen through the device, Hendriks describes stents or stent grafts (¶ [0137], [0140]). As known in the art, a stent or stent-graft comprises a tubular device configured to fluidly couple first and second locations, generally between blood vessels or other physiologic lumens. This implies that the device has a lumen. Hendriks further specifies that the stent or stent graft adjustably restricts a pressure or flow rate through the stent, which requires deforming, collapsing or expanding its lumen.
Claims 3 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks and Shaolian in view of Vecchio; Christopher J. (US 20200197178 A1).
Regarding claims 3 and 31, Hendriks with Shaolian do not explicitly disclose that the inductor is configured to generate a current when exposed to an EMF generated by an energy source positioned within the patient. Vecchio discloses an implantable device comprising electrical components (¶ [0005], [0076], noninvasive methods of monitoring cardiac pressure; ¶ [0077] FIG. 1 shows an implantable medical device 100; ¶ [0118] FIG. 18 shows an example of an implantable medical device 1800 for regulating blood pressure; ¶ [0139] FIG. 21 shows an example of an implantable medical device 1400 being activated by … energization unit 2100);
wherein the inductor is configured to generate a current when exposed to an electromagnetic field generated by an energy source positioned within the patient and spaced apart from the one or more electrical components (¶ [0139] FIG. 21 shows an example of an implantable medical device 1400 being activated by an energy source, for example an energization unit 2100 … the energization unit 2100 is delivered to a location within the heart H (e.g., in the right atrium RA) that is proximate to the membrane 2104).
Vecchio demonstrates that a wirelessly controlled implant can be actuated either externally (¶ [0098] In some examples, the actuation mechanism 108 is external to the body, such as an extracorporeal energization unit 800. FIG. 8 illustrates the implantable medical device 100 or 200); or from a minimally invasive catheter (¶ [0139] FIG. 21 … Unlike the extracorporeal energization unit 800, the energization unit 2100 is delivered to a location within the heart H (e.g., in the right atrium RA) that is proximate to the membrane 2104).
Vecchio’s energy delivery catheter approaches an implant more closely and minimizes the amount of stray EMF that reaches the patient. One would be motivated to modify Hendriks with Shaolian with Vecchio’s internal energy source to more accurately target a controllable implant and minimize the energy delivered to surrounding tissues. Therefore, it would have been obvious to modify Hendriks with Shaolian with Vecchio’s catheter-based energy source in order to minimize stray EMF delivered to the patient.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hendriks and Shaolian in view of Eldridge; David et al. (US 20160181730 A1).
Regarding claim 10, Hendriks and Shaolian are silent whether the actuation element and inductor have approximately the same resistance. Eldridge discloses a Transcutaneous Energy Transfer (TET) system for implanted devices (¶ [0005], [0011], [0057], [0093], FIG. 4, a TET system 100);
comprising an actuation element and one or more electrical components form a resonant circuit that includes the actuation element (¶ [0093], FIG. 4, a TET system 100 comprises two resonant systems, a transmitter resonator 102 and a receiver resonator 104; ¶ [0096] FIG. 5 … The receiver unit 500 can be coupled to a device load 502, such as an implantable medical device);
wherein the actuation element has a first resistance and the inductor has a second resistance, and wherein the first resistance is approximately the same as the second resistance (¶ [0093], In order to excite each resonant system an impedance matching circuit can connect the transmitter resonator to the power source and the receiver resonator to the load. This way the load and power source only have to supply the real part of the power, and the reactive part of the power is handled by the impedance matching circuit; ¶ [0094] In FIG. 4, the impedance matching circuits can comprise voltage dividers formed from capacitors … Voltage divider 108 can be coupled to receiver resonator 104 and can comprise capacitor Cy1 and inductor L1, coupled to the Load).
Eldridge matches the inductance of components in the circuit in order to transfer power optimally (¶ [0093]). One would be motivated to modify Hendriks and Shaolian with Eldridge’s matched resistance or impedance to minimize power losses when wirelessly transferring energy from the transmitter to the receiver and its load. Therefore, it would have been obvious to modify Hendriks with Eldridge’s impedance matching in order to minimize power losses.
Claims 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks in view of Vecchio; Christopher J. (US 20200197178 A1).
Regarding claim 38, Hendriks discloses a method for deploying an adjustable shunting system having a shape memory actuation element (¶ [0020], the wirelessly controllable device may be an implantable device; ¶ [0043], a method of wirelessly controlling a device; ¶ [0079], implantable devices; ¶ [0083], FIG. 3, which shows a system 30 … including a wirelessly controllable device 20 … are in the form of an implantable device);
the method comprising: deploying the adjustable shunting system that includes the shape memory actuation element at a target location within the patient (¶ [0081], stent delivery; ¶ [0085] The remotely controllable device comprises a plurality of actuator elements 22a, 22b, 22c);
wherein the shape memory actuation element at least partially defines a lumen through the adjustable shunting system and is configured to selectively increase and/or selectively decrease a diameter of the lumen (¶ [0135] Particular implantable device applications … include: ¶ [0137] shape adaptation of stent grafts after their placement in order to prevent leakage; ¶ [0140] stents with adaptive restriction which varies over their length); and
wherein the shape memory actuation element is deformed relative to a preferred geometry following deployment of the adjustable shunting system (¶ [0091] The actuator elements 22 in the example of FIG. 3 each comprise a responsive material deformable in response to an electrical stimulus … In further examples, the actuator element may comprise a different responsive material, for instance a smart memory alloy, deformable by thermal stimulation; ¶ [0143], Other responsive materials include, by way of example, heat-responsive shape-memory materials, such as shape-memory alloys and shape memory polymers (stimulated for instance by joule heating)); and
initiating a power transfer between an energy delivery device and the shunting system to induce a current in a resonant circuit that includes the shape memory actuation element (¶ [0098] A controller 36 is operatively coupled with the transmitter coil arrangement 32 … The transmitter coil arrangement comprises one or more inductive coils for supplying electrical energy to the receiver circuits 24 via inductive coupling; ¶ [0102] It can be seen therefore that by applying the exemplary field illustrated by FIG. 4, the field is controlled to sweep through the respective resonant frequencies of each of the receiver circuits 24, and thereby effect sequential activation of each of the actuator elements 22a, 22b, 22c in turn);
wherein the current resistively heats the shape memory actuation element above a transition temperature to cause the shape memory actuation element to move toward the preferred geometry (¶ [0091], In further examples, the actuator element may comprise a different responsive material, for instance a smart memory alloy, deformable by thermal stimulation; ¶ [0143], shape-memory alloys and shape memory polymers (stimulated for instance by joule heating)).
Hendriks lacks an energy delivery catheter. Vecchio discloses an implantable device and method comprising electrical components (¶ [0005], [0076], noninvasive methods of monitoring cardiac pressure; ¶ [0077] FIG. 1 shows an implantable medical device 100; ¶ [0118] FIG. 18 … implantable medical device 1800; ¶ [0139] FIG. 21 … implantable medical device 1400 being activated by … energization unit 2100);
the method comprising: deploying the adjustable shunting system that includes the shape memory actuation element at a target location within the patient (¶ [0089] FIGS. 4 and 5, in certain instances, the implantable medical device 200 may include a pattern of structural frame elements … For example, the pattern of structural frame elements can form a diamond cell pattern in the inner lobes 402a, 402b, and 402c that collapse and open during load and deployment of the implantable medical device 200 in a catheter; ¶ [0115] FIG. 16 shows the implantable medical device 1400 in a compressed configuration inside a deployment apparatus 1600 … the deployment apparatus 1600 includes a catheter or a sheath);
percutaneously advancing an energy delivery catheter toward the shunting system until the energy delivery catheter is proximate the adjustable shunting system; and initiating a power transfer between the energy delivery catheter and the shunting system to induce a current in a resonant circuit that includes the shape memory actuation element (¶ [0139] FIG. 21 shows an example of an implantable medical device 1400 being activated by an energy source, for example an energization unit 2100 … the energization unit 2100 is delivered to a location within the heart H (e.g., in the right atrium RA) that is proximate to the membrane 2104).
Vecchio demonstrates how to actuate an implant either externally or internally (¶ [0098], [0139]). Regarding the rationale and motivation to modify Hendriks with Vecchio’s energy delivery catheter, see the discussion of claims 3 and 31 above.
Regarding claims 39 and 42, Hendriks does not explicitly disclose first and second catheters. Vecchio discloses a method wherein the energy delivery catheter is a first catheter (¶ [0139] FIG. 21 … an energy source, for example an energization unit 2100); and
wherein deploying the adjustable shunting system at the target location includes percutaneously advancing a second catheter different than the first catheter toward the target location, the second catheter carrying the adjustable shunting system (¶ [0089] FIGS. 4 and 5 … For example, the pattern of structural frame elements can form a diamond cell pattern in the inner lobes 402a, 402b, and 402c that collapse and open during load and deployment of the implantable medical device 200 in a catheter; ¶ [0115] FIG. 16 shows the implantable medical device 1400 in a compressed configuration inside a deployment apparatus 1600 … the deployment apparatus 1600 includes a catheter or a sheath);
wherein the transmitter coil does not contact the adjustable shunting system (¶ [0139], The energization unit 2100 functions in a way similar to the extracorporeal energization unit 800 in that the energization unit 2100 can transmit energy to the implantable medical device via magnetic induction).
Vecchio demonstrates how to actuate an implant either externally or internally (¶ [0098], [0139]). Regarding the rationale and motivation to modify Hendriks with Vecchio’s energy delivery catheter, see the discussion of claims 3 and 31 above.
Regarding claims 40 and 41, Hendriks and Vecchio are silent regarding a distance between the transmitter coil and the adjustable shunting system. The coil-to-shunt distance is interpreted as a result-effective variable. The coil-to-shunt distance determines how closely the energy delivery catheter must approach when actuating the actuation element. A skilled artisan would have been able to select a distance between 2-5 cm in order to maneuver through the heart’s small dimensions. For example, Vecchio calls for placing a shunt in the heart’s septum (¶ [0077], The occlusion assembly 104 is configured to be implanted in an organ wall (e.g., a septum of a heart); ¶ [0082] FIG. 2 … The implantable medical device 200 includes a fluid shunt 202 adapted to extend through an organ wall 204 (e.g., a septum)). Therefore, it would have been obvious to select a distance between 2-5 cm since the implant is intended to be placed in a septum wall.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Hendriks and Vecchio in view of Brenneman; Rodney A. et al. (US 20070249985 A1).
Regarding claim 44, Hendriks and Vecchio do not explicitly disclose an asymmetrical lumen cross-section. Brenneman discloses a vascular shunt rivet for cardiac or pulmonary diseases, constituting a shunt (¶ [0002], [0008], [0042] FIG. 1 … shunt rivet 8; ¶ [0062] Yet another variation … FIG. 27, shunt rivet 80);
comprising a shape memory actuation element (¶ [0043] FIG. 2 illustrates the aortocaval shunt rivet 8 in its restrained condition, while FIG. 3 illustrates the aortocaval shunt rivet of FIG. 2 in its resiliently expanded configuration. The shunt rivet may be formed from a single tube 11 of resilient material, such as nitinol, spring steel, glass or carbon composites or polymers, or pseudoelastic (at body temperature) material such as nitinol or comparable alloys and polymers);
wherein following deployment and before initiating a power transfer, the shunt’s lumen has an asymmetrical cross-sectional shape (¶ [0057] The shunt rivet may be modified as shown in FIGS. 22 through 25. FIG. 22 is a perspective view of a shunt rivet 65 in which the clinch members are biased to provide pairs of clinch members 66a and 66v biased to close upon contiguous parallel portions of adjacent vessels and a pair of clinch members 67a and 67v biased to exert slight pressure; ¶ [0062], FIG. 27, shunt rivet 80 may include the longitudinally oriented clinch members 81a, 81a' and 81v, 81v' positioned opposite to one another and transversely oriented clinch members 82a and 82v; ¶ [0066] Aside from the variable length clinch members, shunt rivet 80 may further define one or more slots 83 along the length of the clinch members).
Brenneman demonstrates how to securely anastomose adjacent blood vessels with a shunt (¶ [0042], the left femoral artery provides a nearly straight pathway to a suitable site of the artificial aortocaval fistula 7 within the abdominal aorta … and is maintained by inserting the shunt rivet 8; ¶ [0057], FIG. 22 … pairs of clinch members 66a and 66v biased to close upon contiguous parallel portions of adjacent vessels; ¶ [0062], The respective lengths of clinch members 81a, 81v' relative to 81a', 81v … deployed between adjacent vessels). One would be motivated to modify Hendriks and Vecchio with Brenneman’s asymmetrical cross-section since Hendriks calls for various implantable stents (¶ [0137], [0140]). Therefore, it would have been obvious to modify Hendriks and Vecchio with Brenneman’s asymmetrical cross-section in order to anastomose adjacent blood vessels.
Response to Arguments
The objection to claim 38 for minor informalities and the rejection of claim 37 under 35 USC § 112 are withdrawn in view of the amendments filed 26 September 2025.
Applicant’s arguments filed 26 September 2025 regarding the rejection of claims 1-16 and 29-43 as amended, under 35 USC § 103 over Hendriks, Vecchio, Schaer, Eldridge and Johnson, have been fully considered and are persuasive. After further consideration, the amended claims 1-6, 8-16, 29-34, 36-42 and 44 are rejected on new grounds under 35 USC § 103 over Hendriks, Shaolian, Vecchio, Eldridge and Brenneman (see above).
Applicant’s arguments regarding Schaer and Johnson have been considered but are moot because the references are no longer cited in the current rejection.
Applicant submits that claim 1 has been amended as discussed during the September 23rd telephone interview and that independent claim 29 has been amended to include certain features generally similar to the features of claim 1 discussed during the September 23rd interview (remarks p. 10). Applicant asserts that Vecchio fails to cure the deficiencies of Hendriks to support a prima facie Section 103 rejection of claims 1 or 29 (remarks p. 10). Examiner responds that claims 1 and 29 are rejected in the new grounds of rejection over Hendriks and Shaolian. Shaolian discloses an implant system including an inductor and actuator, where the inductor has a relatively larger surface area, and where the inductor connects electrically to the actuator.
Applicant contends that further, as agreed upon during the September 23rd telephone interview, amended claim 38 is patentable over Hendriks and Vecchio for at least the reason that these references do not teach or suggest each and every feature of this claim (remarks p. 11). Examiner replies that amended claim 38 is rejected over Hendriks and Vecchio because Hendriks describes a sent or stent-graft, which implies that the device includes a lumen (¶ [0137], [0140]).
Applicant submits that Schaer fails to cure the deficiencies of Hendriks to support a prima facie Section 103 rejection of claim 1 (remarks p. 11). Examiner notes that Schaer is not cited in the current grounds of rejection.
Applicant asserts that claim 10 is patentable over the combination of Hendriks and Eldridge for at least the reason that corresponding independent claim 1 is patentable over these references, and for the additional features of this dependent claim (remarks p. 12). Applicant contends that claims 14 and 16 are patentable over the combination of Hendriks and Johnson for at least the reason that corresponding independent claim 1 is patentable over these references, and for the additional features of these dependent claims (remarks p. 12). Examiner notes that Eldridge is cited only as teaching features of dependent claims and Johnson is not cited in the current rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Walsh; Edward G. et al. US 6802857 B1
Shaolian; Samuel et al. US 20060206140 A1
Shaolian; Samuel M. et al. US 20060212113 A1
Tsukashima; Ross et al. US 20120123531 A1
Dagan; Amir et al. US 20180092763 A1
Van Langenhove; Glenn US 20180296375 A1
Kim; Woong US 20180360632 A1
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Tel 571-272-2590
Fax 571-273-2590
Email Adam.Marcetich@uspto.gov
The Examiner can be reached 8am-4pm Mon-Fri.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 571-270-5879. The fax phone number for the organization where this application is assigned is 571-273-8300.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov.
Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Adam Marcetich/
Primary Examiner, Art Unit 3781