DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/05/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/05/2025 and 08/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 05/05/2025 has been entered. Claim 1 has been amended; claims 16-20 have been cancelled. Accordingly, claims 1-15 are pending and under consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1-15 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claim 1 is now rejected as being unpatentable over Rottenberg US 2005/0148925 A1 (previously cited), as cited in the IDS, in view of Schaldach et al. US 2002/0028999 A1 (newly cited). See rejection of claims below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 9, 10, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rottenberg US 2005/0148925 A1 (previously cited, hereinafter Rottenberg), as cited in the IDS, in view of Schaldach et al. US 2002/0028999 A1 (newly cited, hereinafter Schaldach).
Regarding claim 1, Rottenberg discloses a system 1300 (Fig. 13A and 13D – differential pressure regulation device DPRD 1300) for shunting blood between a left atrium and a right atrium of a patient (Par. 33 – “…a Differential Pressure Regulation Device (DPRD), for example, including a shunt, tube or other structure having an orifice, tube or opening to fluidically connect two or more lumens, for example, to connect a left atrium of a heart with a right atrium of the heart”), the system 1300 (Fig. 13A and 13D) comprising:
a shunting element “S” (see annotated Fig. 13D below – shunting element “S” being the body of the DPRD 1300) having a lumen “L” extending therethrough (see annotated Fig. 13D below – lumen “L” extends through the length of DPRD 1300), wherein the lumen “L” (see annotated Fig. 13A and 13D below) is configured to fluidly couple the left atrium “LA” (Fig. 13A – left atrium “LA”) and the right atrium “RA” (Fig. 13A – right atrium “RA”) when the shunting element “S” (see annotated Fig. 13A and 13D below) is implanted in the patient (see annotated Fig. 13A and 13D below – shunting element “S” is implanted in the septal wall);
an actuation element 1380+1377 (Fig. 13D – locking mechanism 1380 and cover 1377, Par. 95 – “cover 1377 may be constructed from a rigid material and may be assembled or connected in a rigid manner to a locking mechanism 1380”), wherein the actuation element 1380+1377 (Fig. 13D) is configured to be selectively energized (Par. 95 – “Once cover 1377 has been set in a selected position by locking mechanism 1380, it may remain stable, for example, not being affected by blood pressure changes, until cover 1377 is re-positioned. In such a case, cover 1377 may only be adjusted by intentional and controlled actions…”) to reduce the likelihood of tissue ingrowth/overgrowth and adhesion (Par. 36 – “the DPRD may be configured such that the orifice cover has no direct contact with the shunt opening to reduce help minimize or prevent tissue growth on or around the orifice cover. Such a configuration may enable a continuous fluid flow through the DPRD, and may help to prevent or reduce the occurrence of clotting or formation of biofilm or other unwanted growth”).
However, Rottenberg does not currently disclose a sensor configured to be implanted in the patient and operably coupled to the shunting element, wherein the sensor is configured to measure one or more parameters of the system and/or one or more physiological parameters of the patient; and an actuation element coupled to the sensor, where in the actuation element is configured to reposition the sensor to reduce the likelihood of tissue ingrowth/overgrowth and adhesion on at least a portion of the sensor.
Schaldach, in the same field of endeavor of implantable measuring device (Title), teaches a sensor 5 (Fig. 1-2 – sensor 5) configured to be implanted in the patient (Abstract – “An implantable pressure measuring device comprises… a pressure-sensitive sensor (5)”, which indicates that the device comprising the sensor is intended to be implanted) and operably coupled to the element 2 (Fig. 1 – main body 2, and Abstract – “a pressure-sensitive sensor (5) on the main body (2)”)), wherein the sensor 5 (Fig. 1-2) is configured to measure one or more parameters of the system and/or one or more physiological parameters of the patient (Par. 18 – “…pressure sensor 5 that detects the prevailing pressure in the artery 4…”); and
an actuation element 6 (Fig. 2, and Par. 10 – cleaning element/piezoceramic actuator 6) coupled to the sensor 5 (Fig. 2, and Par. 10 – “a cleaning element that is coupled to the sensor is provided in the form of a piezoelectric, preferably piezoceramic actuator”), where in the actuation element 6 (Fig. 2) is configured to reposition the sensor 5 (Fig. 1-2) to reduce the likelihood of tissue ingrowth/overgrowth and adhesion on at least a portion of the sensor 5 (Fig. 1-2, and Par. 10 – “a cleaning element that is coupled to the sensor… preferably piezoceramic actuator, which can be set in... mechanical oscillations and thus removing the deposits”).
With the device of Rottenberg being an implanted shunt for regulating heart chamber pressure, one of ordinary skill in the art would have had the technological capability to recognize that having a sensor coupled to said shunt to measure said atrial pressure is critical. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rottenberg to further include a sensor coupled to the shunt as taught by Schaldach, in order to detect prevailing pressure within a patient (Par. 18 of Schaldach).
In addition, both Rottenberg and Schaldach put great emphasis on the reduction of clotting or formation of unwanted tissue growths (Par. 36 of Rottenberg and Par. 5 of Schaldach). Specifically, Schaldach discusses that the sensor surfaces will gradually become covered due to the clot formation, coagulation and endothelialization occurring on the same because of their constant actuation by the blood flow, which causes the sensor sensitivity to be reduced (Par. 5 of Schaldach). Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rottenberg to further have a sensor coupled to the actuation element as taught by Schaldach, in order to remove deposit on the sensor (Par. 10 of Schaldach).
Once the modification is made as discussed, the sensor 5 of Schaldach will be coupled to the actuation element 1380+1377 of Rottenberg. Thus, whenever the locking mechanism 1380+1377 is actuated, e.g. cover 1377 is repositioned (Par. 95 of Rottenberg), the incorporated sensor 5 of Schaldach will also be repositioned, thus removing tissue deposits.
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Annotated Fig. 13A of Rottenberg
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Annotated Fig. 13D of Rottenberg
Regarding claim 2, Rottenberg in view of Schaldach discloses the invention of claim 1. However, Rottenberg in view of Schaldach does not currently explicitly disclose a battery configured to be implanted in the patient and store energy, wherein the energy stored in the battery can be used to actuate the actuation element.
Rottenberg, in another embodiment, teaches further comprising a battery (Par. 91 – “DPRD 1300 may include a ‘receiving’ unit. The receiving unit may include an internal power source (e.g., a battery)…”) configured to be implanted in the patient (Examiner notes that the DPRD is intended to be implanted, thus the internal power source that is a battery is also intended to be implanted) and store energy (Examiner contends that a battery has to store electrical energy), wherein the energy stored in the battery can be used to actuate the actuation element 1380+1377 (Examiner contends that since locking mechanism 1380+1377 is controlled by wire 1375, which is ultimately controlled by the control mechanism 1310 (Par. 95 – “control mechanism 1310 may be used to control DPRD 1300, for example using one or more rods or wires 1375, etc. …”), and control mechanism 1310 can be controlled internally as described in Par. 92 to control DPRD 1300, one of ordinary skill in the art would have recognized that this requires the internal energy of said battery).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Rottenberg in view of Schaldach to further have a battery, as Rottenberg teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.). It is also within the skill of one of ordinary person in the art to create a self-powering implant, in order to eliminate any external power source that might be uncomfortable for the patient.
Regarding claim 9, Rottenberg in view of Schaldach discloses the invention of claim 1. Rottenberg in view of Schaldach further discloses wherein the actuation element 1380+1377 (Fig. 13D of Rottenberg) is mechanically linked to the sensor 5 (Fig. 1-2 of Schaldach).
Examiner notes that once the combination is made as discussed in claim 1, the sensor 5 of Schaldach will be mechanically coupled to the actuation element 1380+1377 of Rotteneberg, i.e. in a flat manner similar to the Fig. 2 of Schaldach on cover 1377 of Rottenberg. Thus, the limitation is met.
Regarding claim 10, Rottenberg in view of Schaldach discloses the invention of claim 1. Rottenberg in view of Schaldach further discloses further comprising a power management system 1310 (Fig. 13A of Rottenberg – control mechanism 1310) configured to be implanted in the patient (Par. 90 of Rottenberg – “Control mechanism 1310 may be a micro mechanism that may be placed internally or externally, for example, it may be sown into tissue under a patient's skin…”) and provide power to the actuation element 1380+1377 (Par. 89 of Rottenberg – “Control mechanism 1310 may include, for example, a mechanical interface, electrical interface, pull/push wire, spring, magnet or other suitable elements or mechanisms to enable DPRD 1300 to be remotely controlled”, and Par. 95 of Rottenberg – “control mechanism 1310 may be used to control DPRD 1300, for example using one or more rods or wires 1375 etc. …”, wherein the wires 1375 provides power/forces to move the actuation element 1380+1377).
Regarding claim 11, Rottenberg in view of Schaldach discloses the invention of claim 1. Rottenberg in view of Schaldach further discloses further comprising a power management system 1310 (Fig. 13A of Rottenberg – control mechanism 1310) configured to be implanted in the patient (Par. 90 of Rottenberg – “Control mechanism 1310 may be a micro mechanism that may be placed internally or externally, for example, it may be sown into tissue under a patient's skin…”) and provide power to the actuation element 1380+1377 (Par. 89 – “Control mechanism 1310 may include, for example, a mechanical interface, electrical interface, pull/push wire, spring, magnet or other suitable elements or mechanisms to enable DPRD 1300 to be remotely controlled”, and Par. 95 of Rottenberg – “control mechanism 1310 may be used to control DPRD 1300, for example using one or more rods or wires 1375 etc. …”, and “intentional and controlled actions using control mechanism 1310, for example, wires 1375 using signals”, wherein the wires 1375 using power/signals to move the actuation element 1380+1377), and wherein the power management system 1310 (Fig. 13A of Rottenberg) is out of electrical communication with the shunting element “S” (see annotated Fig. 13D of Rottenberg above) and the sensor 5 (Fig. 2 of Schaldach, and Fig. 13D of Rottenberg after modification; Par. 95 of Rottenberg – “control mechanism 1310 may be used to control DPRD 1300, for example using one or more rods or wires 1375 etc., optionally operating within tube 1370”, which means the control mechanism 1310 is directly operably coupled to wires 1375 and the locking mechanism 1380+1377; in other words, the control mechanism 1310 cannot directly actuate the shunting element “S” nor the sensor 5 and bypass the mechanism 1380+1377).
Regarding claim 15, Rottenberg in view of Schaldach discloses the invention of claim 1. Rottenberg in view of Schaldach further discloses wherein the sensor 5 (Fig. 1-2 of Schaldach) comprises a first sensor (Examiner notes that after the modification of claim 1, there is one incorporated sensor 5 of Schaldach) and the actuation element 1380+1377 (Fig. 13D of Rottenberg) comprises a first actuation element (Fig. 13D of Rottenberg – there is one locking mechanism and cover present).
However, Rottenberg in view of Schaldach does not disclose wherein the system further comprises a plurality of second sensors and a plurality of second actuation elements coupled to corresponding second sensors, and further wherein the second actuation elements are configured to be selectively energized and transmit desired motion to the second sensors to limit or prevent tissue overgrowth and adhesion on at least a portion of the sensors.
Examiner notes that the rejection of claim 1 above has established how the actuation element is capable of being selectively energized and transmit desired motion to the second sensors to limit or prevent tissue overgrowth and adhesion on at least a portion of the sensors.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the sensor and the actuation elements of Rottenberg in view of Schaldach to further have a plurality of second sensors and corresponding second actuation elements, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. Furthermore, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144. Having the sensors and actuation elements duplicated into discreet components, e.g. another set on the other end of the shunting element will enhance the monitoring experience of the implanted sensor through reading accuracies, thereby improving the regulating of differential pressure between two atria. Furthermore, once the modification is made in claim 1, Rottenberg has established that the actuation element 1380+1377 reduces tissue overgrowth over the sensor 5 via the repositioning of said sensor. Therefore, the duplication of actuation elements will also further facilitate the elimination of cell blockage. Thus, the limitation “the system further comprises a plurality of second sensors and a plurality of second actuation elements coupled to corresponding second sensors, and further wherein the second actuation elements are configured to be selectively energized and transmit desired motion to the second sensors to limit or prevent tissue overgrowth and adhesion on at least a portion of the sensors” is met.
Claims 3, 4, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Rottenberg in view of Schaldach as applied to claim 1 above, and further in view of Lin et al. US 2008/0208083 A1 (previously cited, hereinafter Lin), as cited in the IDS.
Regarding claim 3, Rottenberg in view of Schaldach discloses the invention of claim 1. However, Rottetnberg in view of Schaldach does not disclose wherein the actuation element comprises a shape memory element, and wherein, when selectively energized, the shape memory element is configured to change shape and thereby transmit a desired motion to the sensor.
Lin, the in same field of endeavor of implant devices 10 (Fig. 5A-5B – device 10) with motion-inducing actuator (Abstract), teaches the actuation element 20 (Fig. 1c – actuator 20) comprises a shape memory element (Par. 78 – “Motion-inducing actuators 20… include any… shape memory polymer,… a shape memory alloy,…”), and wherein, when selectively energized (Par. 78 – “Motion-inducing actuators 20… can transduce an amount of energy received…”, thus inferring a predetermined amount of energy), the shape memory element is configured to change shape (Par. 78 – “…can transduce an amount of energy received into movement of the device”; Examiner contends that it is known in the art that shape memory element is capable of shape change given its form revertability).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuation element that is currently a latch-and-lock mechanism of Rottenberg in view of Schaldach for a shape memory element, since these mechanisms perform the same function of inducing a change in movement that is conveyed towards the sensor of Rottenberg in view of Schaldach. Simply substituting one position-changing means for another would yield the predicable result of relaying a change in motion of the sensor. See MPEP 2143. Therefore, the limitation of “thereby transmit a desired motion to the sensor” is met.
Regarding claim 4, Rottenberg in view of Schaldach in view of Lin discloses the invention of claim 3. The combination further discloses wherein the actuation element 20 (Fig. 1c of Lin) is composed of nitinol (Par. 78 of Lin – “a shape memory alloy (such as Nitinol,…”).
Once the combination is made as discussed in claim 3, the actuation element of the combined device will have a shape memory element as taught by Lin, and among the shape memory element listed by Lin, Nitinol is a possible selection. Thus, the limitation is met.
Regarding claim 5, Rottenberg in view of Schaldach in view of Lin discloses the invention of claim 3. Rottenberg in view of Schaldach in view of Lin further discloses wherein the actuation element 20 (Fig. 1c of Lin) is composed of a shape memory polymer (Par. 78 of Lin – “a shape memory polymer”).
Once the combination is made as discussed in claim 3, the actuation element of the combined device will have a shape memory element as taught by Lin, and a shape memory polymer is listed by Lin to be a possible selection. Thus, the limitation is met.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rottenberg in view of Schaldach in view of Lin as applied to claim 3 above, and further in view of Levinson et al. US 2010/0249560 A1 (previously cited, hereinafter Levinson), as cited in the IDS.
Regarding claim 6, Rottenberg in view of Schaldach in view of Lin discloses the invention of claim 3. However, the combination does not disclose wherein the actuation element is composed of a pH-based shape memory material.
Levinson, considered to be analogous art since the invention employs induction of a shape memory effect, i.e. motion change (Par. 103), teaches wherein the actuation element is composed of a pH-based shape memory material (Par. 142 – “The shape memory effect can also be induced by changes in ionic strength or pH”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuation element’s memory shape element of the combination that changes shape and induces a motion change, for the pH-based shape memory material of Levinson since these materials perform the same function of changing its shape upon specific conditions. Simply substituting one memory shape element for another would yield the predicable result of shape deformation/re-formation of the memory shape material and translation of said shape change to resultant motion upon the sensor. See MPEP 2143.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rottenberg in view of Schaldach as applied to claim 1 above, and further in view of Patterson et al. US 6,165,209 A (previously cited, hereinafter Patterson), as cited in the IDS.
Regarding claim 7, Rottenberg in view of Schaldach discloses the invention of claim 1. However, Rottenberg in view of Schaldach does not disclose wherein the actuation element comprises a bi-metallic strip.
Patterson, in the same filed of endeavor of vascular implantation (Abstract), teaches the actuation element 130, 132 (Fig. 4 – actuation member 130, 132) comprises a bi-metallic strip (Col. 6, line 37-40).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the actuation element of Rottenberg in view of Schaldach to further have a bi-metallic strip as taught by Patterson, in order to induce changes in its shape and/or dimensions in response to a change in temperature (Col. 8, line 41-43 of Patterson).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rottenberg in view of Schaldach as applied to claim 1 above, and further in view of Peppou et al. US 2017/0014067 A1 (previously cited, hereinafter Peppou), as cited in the IDS.
Regarding claim 8, Rottenberg in view of Schaldach discloses the invention of claim 1. However, Rottenberg in view of Schaldach does not disclose wherein the actuation element comprises a piezo-electric bimorph.
Peppou, considered to be analogous art since the invention employs actuation devices such as shape memory alloy or bimorph strip (Par. 27) to induce motion, teaches wherein the actuation element comprises a bimorph strip (Par. 27 – “Other examples of electromechanical actuation devices may include… a bimorph strip…”).
Examiner contends that bimorph strip is known by one of ordinary skill in the art to be a type of piezo-actuators.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuation element of Rottenberg in view of Schaldach, which is currently already an electromechanical upon combination of Rottenberg, for a piezoelectric bimorph form as taught by Peppou, since these actuation mechanisms are both electromechanical actuation (Par. 27 of Peppou) and perform the same function of inducing movement upon specific electrical conditions. Simply substituting one electromechanical actuator for another would yield the predicable result of induced motion/movement of the actuator via electrical energy. See MPEP 2143.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rottenberg in view of Schaldach as applied to claim 11 above, and further in view of Penner et al. US 7,617,001 B2 (previously cited, hereinafter Penner), as cited in the IDS.
Regarding claim 12, Rottenberg in view of Schaldach discloses the invention of claim 11. However, Rottenberg in view of Schaldach does not disclose wherein the power management system comprises a power receiver operably coupled to an energy storage component, a switch, and a controller operably coupled between the switch and the actuation element.
Penner, in the same field of endeavor of implantable devices (Title), teaches wherein the power management system (Fig. 1C – diagram shown) comprises a power receiver 116 (Fig. 1C – switch 116) operably coupled to an energy storage component 114 (Fig. 1C – battery 114), a switch 120 (Fig. 1C – switch circuit 120), and a controller 322 (Fig. 1B – controller 322) operably coupled between the switch 116 (Fig. 1C) and the actuation element 326 (Fig. 1C – actuator 326; controller 322 is connected between the switch 116 and the actuator 326).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the power management system of Rottenberg in view of Schaldach to further include a power receiver, energy storage components, a switch, and a controller as taught by Penner, in order to transfer data from the implant and/or to receive instructions for controlling the implant (Abstract of Penner). The arrangement as taught by Penner allows for controlling, monitoring, or otherwise communicating with the implant, while allowing the patient to remain mobile (Abstract of Penner).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Rottenberg in view of Schaldach in view of Penner as applied to claim 12 above, and further in view of Ward et al. US 2009/0036975 A1 (previously cited, hereinafter Ward), as cited in the IDS.
Regarding claim 13, Rottenberg in view of Schaldach in view of Penner discloses the invention of claim 12. However, the combination does not disclose wherein the power receiver comprises a piezoelectric element configured to harvest energy from intentional or incidental bodily motion of the patient, pulsatile cardiac tissue motion, pulsatile hydraulic pressure variation in blood, and/or pulsatile Venturi effect pressure variations due to varying blood flow through the lumen.
Penner, in the same field of endeavor of implantable devices (Title) and in another embodiment, teaches wherein the power receiver (Fig. 2 – switch 400) comprises a piezoelectric element (Col. 7, line 3-4 – “The switch 400 includes a piezoelectric transducer…”).
Ward, in the same field of endeavor of self-powering implant (Abstract), teaches a piezoelectric element (Par. 87 – “PVDF materials, i.e. piezoelectrical material”) configured to harvest energy from intentional or incidental bodily motion of the patient (Par. 14 of Ward – “an energy harvesting structure comprising at least one piezoelectric material situatable in a region of a biologic structure (such as, e.g., a biologic structure within a living patient, a biologic structure within a living organism, etc.)” and Par. 31 of Ward – “piezoelectric materials… are the only known materials from which energy can be harvested in response to mechanical forces”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the power receiver of the combination to further have a piezoelectric material, also as taught by Penner, as Penner teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Furthermore, once the modification is made as discussed, the modified piezoelectric material will be able to harvest energy from a patient as taught by Ward because Ward already discusses in Par. 31 that we use piezoelectric materials in this invention because those are the only known materials from which energy can be harvested in response to mechanical forces. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the piezoelectric material as taught by Ward, in order to convert mechanical energy into electrical energy (Par. 28 of Ward), which will provide information for further processing at subsequent step at the actuation element.
Regarding claim 14, Rottenberg in view of Schaldach in view of Penner discloses the invention of claim 12. The combination further discloses wherein the power receiver 116 (Fig. 1C of Penner – switch 116) is configured to receive electromagnetic energy from ambient fields (Col. 1, 57-60 of Penner – “…electromagnetic energy may be used to control an implant, since a body generally does not attenuate magnetic fields…”).
However, the combination does not disclose comprising one or more of the following: a radio receiver circuit capturing energy from cellular communications, WiFi, Bluetooth, WLAN (wireless local area network), WPAN (wireless personal area network), and WBAN (wireless body area network).
Ward, in the same field of endeavor of self-powering implant (Abstract), teaches comprising WLAN (wireless local area network) (Par. 41 of Ward – “Examples of a wireless receiver [902] are, e.g., NanoNet TRX, Crossbow MICA2 Mote, and Microstrain G-link Wireless acceleration system”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the power receiver of the combination to further receive electromagnetic energy comprising WLAN as taught by Ward, in order to receive communication from a remote device for adjusting the implant (Par. 37 of Ward).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rowe et al. US 20230022499 A1
McNamara et al. US 10413284 B2
Gross US 8923973 B2
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/QUYNH DAO LE/Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781