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 .
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Regarding arguments with respect to independent claim 35 under section A, with respect to the rejection in view of Barakat and Hunter, it is stated that Barakat does not illustrate sensors fixed to a mid-point between vertices, and that Toth was also not relied upon to teach claim 35. Examiner disagrees As per figure 1 of Bakarat, part 12 is disclosed as being the stent, wherein part 16 is the measurement circuit as per [0095]. As such, the impedance sensors extend across the mid-point of a side of the stent. As the stent is by definition “a deformable mesh” in paragraph [0003] of Bakarat, and with meshes being known in the art to have vertices between the wire components of the mesh, and the device of Bakarat is disclosed as being a stent, the sensors of Bakarat are disposed on a mesh with vertices. To that end, as the sensors are on a side of a stent and extend across the mid-point of the device, the sensors of Bakarat broadly read upon the limitations of independent claim 35. With respect to the recitation of Toth, Toth was cited in the last response with respect to claim 47 with respect to the prior response to arguments.
With respect to the rejection of claim 47 in view of Toth, covering sections B and C of the provided arguments, it is stated on page 3 of the applicants arguments and remarks that the sensor of figure 11 of Toth is not at a mid-point between two vertices. Examiner disagrees. As what is claimed in claim 47 is that the sensors are “fixed to a mid-point between to vertices, that are adjacent along a pathway of a wire of the tubular mesh.” As such, what is required is a fixing to a midpoint, where the sensors of Toth were implemented into Barakat and Hunter such that sensors 1640 a-f can be placed within a vertices of a mesh without impeding the function of the sensors. As such, Toth was relied upon to teach sensors that can be placed at the midpoint of vertices that are adjacent to one another, where the sensors of figures 11 and 16 of Toth are placed into Hunter and Barakat with results predictable to one of ordinary skill in the art.
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.
Claim(s) 35, 37, 39, and 41-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barakat (US Pub No.: 2018/0235545) in view of Toth (US Pub No.: 2014/0081154).
Regarding claim 35, Barakat (US Pub No.: 2018/0235545) discloses an apparatus (medical device in the abstract), comprising: a tubular mesh comprising an abluminal surface, the abluminal surface configured to contact a wall of a vascular cavity when the tubular mesh is disposed in the vascular cavity (Stent disclosed in [0002] which involves an abluminal surface to contact a vascular cavity. Abluminal surface of a vascular stent disclosed in [0029]) a plurality of impedance sensors (sensors in [0002] with impedance sensing in [0011] and [0015]), wherein one or more of the plurality of impedance sensors are positioned on the abluminal surface of the tubular mesh (disclosed in [0029] and [0043]) and one or more second impedance sensors of the plurality of impedance sensors are positioned on a luminal surface (as at least two impedance sensors are present in [0014], said second impedance sensor will be the one or more second impedance sensors. Luminal placement of a senser on a stent in [0067]-[0068] and [0121]) of the tubular mesh, and a communication circuit configured to communicate data regarding impedance from the
Barakat does not teach wherein the one or more impedance sensors are fixed to a mid-point between two vertices that are adjacent along a pathway of a wire of the tubular mesh. Instead, Toth teaches wherein the one or more impedance sensors are fixed to a mid-point between two vertices that are adjacent along a pathway of a wire of the tubular mesh (in an alternate embodiment in figure 16, parts 1640 a-f are sensors as per [0179], where sensors 1640e and 1640b are depicted at being at a midpoint of the side of the stent in figure 16, where the sensors 1640 a-f can be placed within a vertices of a mesh without impeding the function of the sensors. Additionally, the intersecting portions between 1130 and 1140 in figure 11 comprise a vertex where part 1020 and 1120, defined as communication modules, are part of sensors in [0171]-[0172]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensor arrangement of Toth into Barakat in order to provide a network of sensors (as per [0179]) that measure impedances over different portions of a stent device, also in [0179]). The sensors of Toth can be placed onto the mid-point between two vertices on the mesh of Barakat with predictable results, as the sensors of Toth are sensors on the outside of a stent (shown in figures 2-3 of Toth).
Regarding claim 37, Barakat in view of Toth teaches the stent of claim 35, wherein Barakat discloses: the apparatus comprises a mesh (stents by definition comprise a mesh, as per [0003]); and one or more of the plurality of impedance sensors are fixed to a vertex of the tubular mesh (as the sensor may be arranged on the abluminal surface of the stent in [0043], the abluminal surface would be the vertex of the stent (that comprises a mesh, where the stent is tubular) as this would be the outer most surface of the stent) .
Regarding claim 39, Barakat in view of Toth teaches the apparatus of claim 35, wherein Barakat discloses: at least some of the impedance sensors of the one or more first impedance sensors and the one or more second impedance sensors are disposed at opposite positions at common points along a body of the tubular mesh (as the sensors extend across the body of the stent as per figure 1 where part 12 is the sensor, and as the sensors are on the luminal and abluminal surfaces (disclosed in [0067]), the sensors are located at opposite positions in an instance wherein sensors are on both the luminal and abluminal surface).
Regarding claim 41, Barakat in view of Toth teaches the apparatus of claim 35, wherein Barakat discloses: the tubular mesh comprises a plurality of measurement lines (parts 62, as defined in [0098], may be arranged into measurement lines), wherein each of the plurality of measurement lines comprises two or more of the plurality of impedance sensors (two parts 62 can be separated by a measurement line. The device of Barakat may have more than three parts 62 but only 3 parts are pictured).
Regarding claim 42, Barakat in view of Toth teaches the apparatus of claim 35, with Barakat further comprising: an hyperplasia-limiting coating on one or more of the plurality of impedance sensors (active agent coated on a sensors for limiting hyperplasia in [0069]).
Regarding claim 43, Barakat in view of Toth teaches the apparatus of claim 35, wherein Barakat discloses: the tubular mesh comprises an electronic measurement circuit (disclosed in [0015], shown in figures 1-2), wherein the plurality of impedance sensors are connected to the electronic measurement circuit (disclosed in [0015]); and the electronic measurement circuit is implanted in an electrically insulating and biocompatible polymeric substrate (measurement electrodes with an electrically insulating biocompatible polymer substrate is present in [0111]. As the electrodes are disclosed to be the modules 62 in [0098] which are the electronic circuits for the impedance sensors) .
Regarding claim 44, Barakat in view of Toth teaches the apparatus of claim 35, wherein Barakat discloses: the plurality of impedance sensors are arranged in series in a measurement line (in figure 5 and [0098]); and each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches (the switch part 24 in [0098]. While only one part 24 is labeled in figure 5, three switches are present in figure 5, one per part 62), wherein each of the plurality of switches are configured to regulate power to a respective impedance sensor of the plurality of impedance sensors (the switch may be a transistor or may be commanded by a resistor or a capacitor in [0098]. As such, the switch regulates a power passing through it as per the teachings of [0096]-[0098]).
Regarding claim 45, Barakat in view of Toth teaches the apparatus of claim 35, wherein Barakat discloses: the plurality of impedance sensors are arranged in a plurality of measurement lines (that parts 62, as defined in [0098], may be arranged into measurement lines); a measurement line of the plurality of measurement lines comprises at least two impedance sensors arranged in series (two parts 62 can be separated by a measurement line. The device of Barakat may have more than three parts 62 but only 3 parts are pictured); and each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches (the switch part 24 in [0098]. While only one part 24 is labeled in figure 5, three switches are present in figure 5, one per part 62) to regulate power to each of the plurality of impedance sensors (the switch may be a transistor or may be commanded by a resistor or a capacitor in [0098]. As such, the switch regulates a power passing through it as per the teachings of [0096]-[0098]).
Regarding claim 46, Barakat in view of Toth teaches the apparatus of claim 35, with Barakat further comprising a plurality of control circuits arranged in series with respect to one another (being the control modules 28 that control the switch 24 in [0097]), wherein: the plurality of impedance sensors are arranged in series (shown in figure 5, with parts 62 being the impedance sensors) in a plurality of measurement lines (parts 62, as defined in [0098], may be arranged into measurement lines); each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches (the switch part 24 in [0098]. While only one part 24 is labeled in figure 5, three switches are present in figure 5, one per part 62); and each control circuit of the plurality of control circuits is configured to control one or more associated switches of the plurality of switches to regulate power to a respective impedance sensor of the plurality of impedance sensors (the switch may be a transistor or may be commanded by a resistor or a capacitor in [0098]. As such, the switch regulates a power passing through it as per the teachings of [0096]-[0098]).
Claim(s) 47, 49-52, and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barakat (US Pub No.: 2018/0235545) in view of Hunter (US Pub. No.: 2016/0310077) and Toth (US Pub No.: 2014/0081154).
Regarding claim 47, Barakat discloses a medical system, comprising: an implantable medical device (in the abstract), comprising: a tubular mesh configured to contact a wall of a vascular cavity (as per the definition of a stent, device disclosed as a stent in [0002] and [0062]) a measurement circuit comprising one or more impedance sensors (shown in figure 5 with sensors being parts 22, disclosed as being impedance sensors in [0079]); wherein the one or more impedance sensors are positioned on each of an abluminal surface and a luminal surface of the tubular mesh (sensors are on the luminal and abluminal surfaces in [0067]), and wherein the one or more impedance sensors are fixed to a mid-point between vertices of the tubular mesh (in figure 1, part 12 is disclosed as being the stent, wherein part 16 is the measurement circuit as per [0095]. As such, the impedance sensors extend across the mid-point of a side of the stent); and a power source (disclosed in [0113]); and a computing device configured to communicate with the implantable medical device and receive data regarding impedance from the implantable medical device (communication circuit in [0012] with a system for receiving data in [0044]-[0046]).
However, Barakat does not teach one or more second impedance sensors of the plurality of impedance sensors are positioned on the luminal surface
Instead, Hunter (US Pub. No.: 2016/0310077) teaches one or more sensors are positioned on the luminal surface (being sensor 10, defined in [0088] and depicted on a luminal surface in figures 18-19. Sensors in a medical device disclosed in [0072] and [0075], where a contact of the sensor 10 with a luminal surface shown in figure 11 and in [0190]. Current based contact for sensors in [0234] also implies impedance based sensors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensors and the arrangement thereof presented in Hunter into the device of Barakat in order to allow for a sensing of the stent graft itself to monitor the integrity of the stent, as per [0190]. Sensing within a stent graft can also sense properties of blood flowing through a graft (as per [0190] of Hunter) where the sensors of Hunter are arranged on a luminal surface of a stent as is present in [0121] of Barakat.
Barakat also does not teach wherein the one or more impedance sensors are fixed to a mid-point between two vertices that are adjacent along a pathway of a wire of the tubular mesh. Instead, Toth teaches wherein the one or more impedance sensors are fixed to a mid-point between two vertices that are adjacent along a pathway of a wire of the tubular mesh (in an alternate embodiment in figure 16, parts 1640 a-f are sensors as per [0179], where sensors 1640e and 1640b are depicted at being at a midpoint of the side of the stent in figure 16, where the sensors 1640 a-f can be placed within a vertices of a mesh without impeding the function of the sensors. Additionally, the intersecting portions between 1130 and 1140 in figure 11 comprise a vertex where part 1020 and 1120, defined as communication modules, are part of sensors in [0171]-[0172]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensor arrangement of Toth into Barakat in order to provide a network of sensors (as per [0179]) that measure impedances over different portions of a stent device, also in [0179]) The sensors of Toth can be placed onto the mid-point between two vertices on the mesh of Barakat with predictable results, as the sensors of Toth are sensors on the outside of a stent (shown in figures 2-3 of Toth).
Regarding claim 49, Barakat in view of Hunter and Toth teach the medical system of claim 47, wherein Barakat discloses the measurement circuit further comprises: a resistor between two sensors of the one or more impedance sensors (the resistor part 40 is between the different sensors 22 in figure 5 and [0098]), wherein the resistor comprises a fixed impedance (as the resistor is not disclosed to have a variable resistance (i.e. a potentiometer), the impedance across the resistor would remain constant in the circuits 62).
Regarding claim 50, Barakat in view of Hunter and Toth teach the medical system of claim 47, wherein Barakat discloses the implantable medical device further comprises: a plurality of measurement circuits (figure 5 parts 62), each comprising a measurement line comprising one or more sensors (parts 62 can be separated by a measurement line. The device of Barakat may have more than three parts 62 but only 3 parts are pictured), wherein the plurality of measurement lines are mounted in parallel (as parts 62 are parallel in figure 5, the measurement lines would also be in parallel); and a plurality of line selectors (parts 44 and 46 in figure 5, detailed in [0099]-[0107] that are connected to a transistor 66), wherein each line selector of the plurality of line selectors is associated with a respective measurement line and configured to control current supply to the respective measurement line (as parts 44 and 46 interface with transistors in [0099]-[0107], a control of a current supply is present via said transistors).
Regarding claim 51, Barakat in view of Hunter and Toth teach the medical system of claim 47, wherein Barakat discloses the computing device further comprises an antenna configured to emit an electromagnetic field to induce power in the measurement circuit (being the antenna part 18 in [0093]-[0094] that does emit an electromagnetic field).
Regarding claim 52, Barakat in view of Hunter and Toth teach the medical system of claim 47, wherein Barakat discloses the measurement circuit of the implantable medical device comprises at least one circuit to generate an electrical signal at a frequency (in [0094]), the electrical signal to be applied to anatomy contacted by the implantable medical device and to be received by an impedance sensor of the one or more impedance sensors (the frequency is disclosed for use in the measurement circuit in [0094], where the measurement circuit would include the impedance sensors).
Regarding claim 55, Bakarat in view of Hunter and Toth teach the apparatus of claim 35, wherein Barakat discloses the apparatus is a stent (in [0002] and [0062] of Bakarat)
Claim(s) 35, 37, 39, 41, 43, 47 and 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toth (US Pub No.: 2014/0081154) in view of Hunter (US Pub. No.: 2016/0310077).
Regarding claim 35, Toth (US Pub No.: 2014/0081154) discloses an apparatus (in [0002] and shown in figure 2), comprising: a tubular mesh comprising an abluminal surface and a luminal surface (the device of figure 2 will have a tubular mesh with luminal and abluminal surfaces), the abluminal surface configured to contact a wall of a vascular cavity when the tubular mesh is disposed in the vascular cavity (the abluminal surface being the outer surface of the device of figure 2. As said apparatus is a stent, said outer abluminal wall will contact a vascular cavity) a plurality of impedance sensors (plurality of sensory modules that may be impedance sensors in [0090]), wherein one or more first impedance sensors of the plurality of impedance sensors are positioned on an abluminal surface of the tubular mesh (as per [0122], the sensors are on part 230 that is depicted as being on an outer surface of the stent, which would be the abluminal surface) and wherein the one or more first impedance sensors or the one or more second impedance sensors are fixed to a mid-point between vertices of the tubular mesh (in an alternate embodiment in figure 16, parts 1640 a-f are sensors as per [0179], where sensors 1640e and 1640b are depicted at being at a midpoint of the side of the stent in figure 16. It would be obvious to incorporate this sensor configuration into the device of figure 2 for the purpose of providing a network of sensors that can measure an impedance across various points of the stent, as disclosed in [0179]); and a communication circuit (being communication module 220, present in [0110]) configured to communicate data regarding impedance from the stent to a computing device (the communication module receives data from the sensory module in [0114], where the communication module would transmit sensed information as per [0089]); wherein the stent is configured to be implanted in a body of a patient (in [0002], [0006], and [0008]-[0009]).
However, Toth does not teach one or more second impedance sensors of the plurality of impedance sensors are positioned on the luminal surface
Instead, Hunter (US Pub. No.: 2016/0310077) teaches one or more sensors are positioned on the luminal surface (being sensor 10, defined in [0088] and depicted on a luminal surface in figures 18-19. Sensors in a medical device disclosed in [0072] and [0075], where a contact of the sensor 10 with a luminal surface shown in figure 11 and in [0190]. Current based contact for sensors in [0234] also implies impedance based sensors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensors and the arrangement thereof presented in Hunter into the device of Barakat in order to allow for a sensing of the stent graft itself to monitor the integrity of the stent, as per [0190]. Sensing within a stent graft can also sense properties of blood flowing through a graft (as per [0190] of Hunter) where the sensors of Hunter are arranged on a luminal surface of a stent as is present in [0121] of Toth.
Regarding claim 37, Toth in view of Hunter teaches the apparatus of claim 35, wherein Toth discloses: the stent comprises a mesh (a stent by definition would comprise a mesh, with a mesh disclosed in [0028]); and one or more of the plurality of impedance sensors are fixed to a vertex of the mesh (as the sensor 230 are on the outside of the stent in figure 2, it the outside would be considered the highest point or vertex of a stent).
Regarding claim 39, Toth discloses the apparatus of claim 35, However, Toth does not disclose at least some impedance sensors of the one or more first impedance sensors and the one or more second impedance sensors are disposed at opposite positions at common points along a body of the tubular mesh.
Instead, Hunter (US Pub No.: 2016/0310077) and at least some impedance sensors of the one or more first impedance sensors and the one or more second impedance sensors are disposed at opposite positions at common points along a body of the tubular mesh (as the sensor module in Hunter is part 10 in figure 11 as per [0086] and as the sensors of Toth are along the outside of the stent device, the sensors would overlap but be on opposing surfaces (i.e. the luminal and abluminal surfaces of the stent). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the luminal sensors and placement details thereof of Hunter into Toth for the purpose of providing a sensor on the inside of a stent that could be used to “monitor the integrity and efficaciousness of the medical device” as per [0008] of Hunter. Additionally, the impedance sensors of Toth can be incorporated into the positions taught by Hunter (i.e. being on a luminal surface) would be known in the art and would allow for a measurement of specific properties (like of the stent or a blood flow as per [0180] and [0190]) that would be beneficial for a medical monitoring of a patient).
Regarding claim 41, Toth in view of Hunter teaches the apparatus of claim 35, wherein Toth discloses: the tubular mesh comprises a plurality of measurement lines (while lines aren’t specifically disclosed as measurement lines in figure 16, lines are present in figure 16), wherein each of the plurality of measurement lines comprises two or more of the plurality of impedance sensors (the sensors 1640 a-f can be grouped in measurement lines such that two sensors (i.e. 1640a and d, 1640b and e, and 1640c and f) can be grouped together).
Regarding claim 43, Toth in view of Hunter teaches the apparatus of claim 35, wherein Toth discloses: the stent comprises an electronic measurement circuit (being parts 222 and 220 with connectors 240a and 240b in figure 2), wherein the plurality of impedance sensors are connected to the electronic measurement circuit (the sensors are in part 230 that are connected to the rest of the circuit via 240a); and the electronic measurement circuit is implanted in an electrically insulating and biocompatible polymeric substrate (disclosed in [0033]-[0034]).
Regarding claim 47, Toth discloses a medical system (in figure 2 and the abstract), comprising: an implantable medical device (being the stent in [0002]), comprising: a tubular mesh configured to contact a wall of a vascular cavity (the device of figure 2 will have a tubular mesh with luminal and abluminal surfaces) a measurement circuit comprising one or more impedance sensors (the circuit being the system 110 with plurality of sensory modules that may be impedance sensors in [0090]); and a power source (part 122 in figure 1, 222 in figure 2); wherein the one or more impedance sensors are positioned on each of an abluminal surface and a luminal surface of the tubular mesh (as per [0122], the sensors are on part 230 that is depicted as being on an outer surface of the stent, which would be the abluminal surface), and wherein the one or more impedance sensors are fixed to a mid-point between two vertices that are adjacent along a pathway of a wire of the tubular mesh (in an alternate embodiment in figure 16, parts 1640 a-f are sensors as per [0179], where sensors 1640e and 1640b are depicted at being at a midpoint of the side of the stent in figure 16. It would be obvious to incorporate this sensor configuration into the device of figure 2 for the purpose of providing a network of sensors that can measure an impedance across various points of the stent, as disclosed in [0179]. Additionally, the intersecting portions between 1130 and 1140 in figure 11 comprise a vertex where part 1020 and 1120, defined as communication modules, are part of sensors in [0171]-[0172]); and a computing device configured to communicate with the implantable medical device and receive data regarding impedance from the implantable medical device (being the “associated reader, and/or an external analysis center” in [0194]. Communication modules to allow for said communication between an implantable device and external system is disclosed in [0197]).
However, Barakat does not teach one or more second impedance sensors of the plurality of impedance sensors are positioned on the luminal surface
Instead, Hunter (US Pub. No.: 2016/0310077) teaches one or more sensors are positioned on the luminal surface (being sensor 10, defined in [0088] and depicted on a luminal surface in figures 18-19. Sensors in a medical device disclosed in [0072] and [0075], where a contact of the sensor 10 with a luminal surface shown in figure 11 and in [0190]. Current based contact for sensors in [0234] also implies impedance based sensors). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensors and the arrangement thereof presented in Hunter into the device of Barakat in order to allow for a sensing of the stent graft itself to monitor the integrity of the stent, as per [0190]. Sensing within a stent graft can also sense properties of blood flowing through a graft (as per [0190] of Hunter) where the sensors of Hunter are arranged on a luminal surface of a stent as is present in [0121] of Barakat.
Regarding claim 55, Toth in view of Hunter teaches the apparatus of claim 35, wherein Toth discloses the apparatus is a stent (in [0002] and shown in figure 2 of Bakarat).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barakat (US Pub No.: 2018/0235545) in view of Hunter (US Pub. No.: 2016/0310077) and Hastings (US Pub No.: 2011/0307034).
Regarding claim 40, Barakat in view of Hunter teaches the apparatus of claim 35, wherein, wherein Barakat discloses the tubular mesh comprises a plurality of struts; the stent comprises a plurality of measurement lines (parts 62, as defined in [0098], may be arranged into measurement lines), wherein each of the plurality of measurement lines comprises two or more of the plurality of impedance sensors (two parts 62 can be separated by a measurement line. The device of Barakat may have more than three parts 62 but only 3 parts are pictured).
However, Barakat does not teach an instance wherein the mesh comprises a plurality of struts; the tubular comprises a plurality of measurement lines and the plurality of measurement lines are woven between struts of the plurality of struts.
Instead, Hastings (US Pub No.: 2011/0307034) discloses an instance wherein the mesh comprises a plurality of struts (in [0021]); the tubular mesh comprises a plurality of measurement lines and the plurality of measurement lines are woven between struts of the plurality of struts (Barakat teaches measurement lines to which the sensor of Barakat can be incorporated into Hastings such that the defined measurement lines and sensors would be incorporated into the struts of Hastings. As an antenna and cathode are attached to the struts as per [0099] and [0119], the tubular mesh and struts of Hastings can incorporate a measurement circuit as presented in Barakat into the device of Hastings). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the stent structure of Hastings into Barakat for the purpose of providing a specific stent structure not taught in Barakat, where struts are known for allowing for a flexibility in a stent.
From here, Barakat in view of Hastings would not teach that the sensors are “woven” between the struts of the tubular mesh. Instead, Hunter (US Pub No.: 2016/0310077) discloses a sensor that is woven into a tubular mesh (a sensor that is associated with woven materials in [0546] and a sensor being woven into a stent graft or incorporated into the metal of a supported graft in [0330], wherein the metal is part of a stent strut as the struts are defined as being metallic in [0166] and [0176]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the weaving of a sensor of Hunter into Barakat in view of Hastings for the purpose of providing a specific stent structure not taught in Barakat in view of Hastings that would allow the sensors of Barakat to be attached to the stent of Hastings. A woven interface is known in the art to be beneficial as the weaving would allow for a secure interface between sensor and device, with a weaving being known in the art to be able to attach a sensor to a mesh, as per [0557].
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barakat (US Pub No.: 2018/0235545) in view of Hunter (US Pub. No.: 2016/0310077), Toth (US Pub No.: 2014/0081154), and Stanley (US Pub No.: 2016/0077030).
Regarding claim 48, Barakat in view of Hunter and Toth teach the medical system of claim 47, wherein Barakat discloses the implantable medical device further comprises: an antenna to emit an electromagnetic field according to an impedance of the measurement circuit (being the antenna part 18 in [0093]-[0094] that does emit an electromagnetic field).
However, Barakat does not teach an analogue/digital converter situated between the measurement circuit and the antenna.
Instead, Stanley (US Pub No.:2016/0077030) does teach an analog/digital converter (in [0050]) situated between the measurement circuit and the antenna (the converter of Stanley can be incorporated between a measurement circuit and antenna of Barakat. Figures 1 and 5 of Stanley shows the converter 165 in a measurement circuit). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the analog to digital converter of Stanley into Barakat for the purpose of providing a means to convert a signal into Barakat. As Barakat discloses an AC generator that will supply a DC current in paragraph [0094], it stands to reason that a signal converter between the measurement circuit and the antenna (where the antenna is disclosed in Barakat to supply a power) is required. The converter would also allow for an adjustment of a gain in the circuit as per [0050].
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth (US Pub No.: 2014/0081154) in view of Hunter (US Pub. No.: 2016/0310077) and Hastings (US Pub No.: 2011/0307034).
Regarding claim 40, Toth in view of Hunter teaches the apparatus of claim 35, wherein: Toth discloses the tubular mesh comprises a plurality of measurement lines (the sensors 1640 a-f can be grouped in measurement lines such that two sensors (i.e. 1640a and d, 1640b and e, and 1640c and f) can be grouped together).
However, Toth does not teach an instance wherein the tubular mesh comprises a plurality of struts; the stent comprises a plurality of measurement lines and the plurality of measurement lines are woven between struts of the plurality of struts.
Instead, Hastings (US Pub No.: 2011/0307034) discloses an instance wherein the tubular mesh comprises a plurality of struts (in [0021]); the stent comprises a plurality of measurement lines and the plurality of measurement lines are woven between struts of the plurality of struts (Toth teaches measurement lines, mentioned above, to which the sensors of Toth can be incorporated into Hastings such that the defined measurement lines and sensors would be incorporated into the struts of Hastings. As an antenna and cathode are attached to the struts as per [0099] and [0119], the stent and struts of Hastings can incorporate a measurement circuit as presented in Toth into the stent of Hastings). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the stent structure of Hastings into Barakat for the purpose of providing a specific stent structure not taught in Toth, where struts are known for allowing for a flexibility in a stent.
From here, Toth in view of Hastings would not teach that the sensors are “woven” between the struts of the plurality of struts. Instead, Hunter (US Pub No.: 2016/0310077) discloses a sensor that is woven into a tubular mesh (a sensor that is associated with woven materials in [0546] and a sensor being woven into a stent graft or incorporated into the metal of a supported graft in [0330], wherein the metal is to be a part of a stent strut as the struts are defined as being metallic in [0166] and [0176]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the weaving of a sensor of Hunter into Toth in view of Hastings for the purpose of providing a specific stent structure not taught in Toth in view of Hastings that would allow the sensors of Toth to be attached to the stent of Hastings. A woven interface is known in the art to be beneficial as the weaving would allow for a secure interface between sensor and device, with a weaving being known in the art to be able to attach a sensor to a mesh, as per [0557].
Claim(s) 41, 44-46 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth (US Pub No.: 2014/0081154) in view of Hunter (US Pub. No.: 2016/0310077) and Hastings (US Pub No.: 2011/0307034).
Regarding claim 44, Toth in view of Hunter teaches the apparatus of claim 35, wherein Toth discloses: the plurality of impedance sensors are arranged in series in a measurement line (the sensors 1640 a-f can be grouped in measurement lines such that two sensors (i.e. 1640a and d, 1640b and e, and 1640c and f) can be grouped together). However, Toth does not teach an instance wherein each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches, wherein each of the plurality of switches are configured to regulate power to a respective impedance sensor of the plurality of impedance sensors.
Instead, Hastings (US Pub No.: 2011/0307034) does teach an instance wherein each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches (electrodes connected to a switch in [0091]. Electrodes disclosed for sensing in [0129]), wherein each of the plurality of switches are configured to regulate power to a respective impedance sensor of the plurality of impedance sensors (as the switch is configured to facilitate switching of components “to selectively charge the electrode arrangement” in [0091]. As such, the switch does control the power to the sensory electrode to charge it). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the switches of Hastings into Toth for the purpose of providing a system to control a current flow from a battery to an electrode (as per [0152]), allowing for a control of a powering of an electrode via an I/O interface. While an electrode for therapy is present in Hastings, a switch to control sensory electrodes is implied in [0148]-[0149] with impedance sensing also present in [0129].
Regarding claim 45, Toth in view of Hunter teaches the apparatus of claim 35, wherein Toth discloses: the plurality of impedance sensors are arranged in a plurality of measurement lines (the sensors 1640 a-f can be grouped in measurement lines such that two sensors (i.e. 1640a and d, 1640b and e, and 1640c and f) can be grouped together); a measurement line of the plurality of measurement lines comprises at least two impedance sensors arranged in series (the sensor groups of two 1640a and d, 1640b and e, and 1640c and f are taken to be in series in figure 16).
However, Toth does not teach that each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches to regulate power to each of the plurality of impedance sensors.
Instead, Hastings does teach that each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches to regulate power to each of the plurality of impedance sensors (electrodes connected to a switch in [0091]. Electrodes disclosed for sensing in [0129]. As the switch is configured to facilitate switching of components “to selectively charge the electrode arrangement” in [0091]. As such, the switch does control the power to the sensory electrode to charge it). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the switches of Hastings into Toth for the purpose of providing a system to control a current flow from a battery to an electrode (as per [0152]), allowing for a control of a powering of an electrode via an I/O interface. While an electrode for therapy is present in Hastings, a switch to control sensory electrodes is implied in [0148]-[0149] with impedance sensing also present in [0129].
Regarding claim 46, Toth in view of Hunter teaches the apparatus of claim 35, with Toth further comprising a plurality of control circuits arranged in series with respect to one another (parts 222 and 220 in figure 2 are analogous to a control unit as both parts would control an operation of a sensor module in 230 and the sensor modules in figure 16), wherein: the plurality of impedance sensors are arranged in series in a plurality of measurement lines (the sensors 1640 a-f can be grouped in measurement lines such that two sensors (i.e. 1640a and d, 1640b and e, and 1640c and f) can be grouped together). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the sensor arrangement of figure 16 of Toth into the device of figure 2 of Toth as the sensor arrangement of figure 16 allows for a sensing of a plurality of impedances to form an impedance map, while figure 2 claims a power supply part 222 that is not shown in figure 16.
However, Toth does not teach that each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches; and each control circuit of the plurality of control circuits is configured to control one or more associated switches of the plurality of switches to regulate power to a respective impedance sensor of the plurality of impedance sensors.
Instead, Hastings would teach that each impedance sensor of the plurality of impedance sensors is associated with a respective switch of a plurality of switches (electrodes connected to a switch in [0091]. Electrodes disclosed for sensing in [0129]); and each control circuit of the plurality of control circuits is configured to control one or more associated switches of the plurality of switches to regulate power to a respective impedance sensor of the plurality of impedance sensors (as the switch is configured to facilitate switching of components “to selectively charge the electrode arrangement” in [0091]. As such, the switch does control the power to the sensory electrode to charge it. The control circuit of Hastings would be the microprocessor and IO interface detailed in [0152]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the switches with the microprocessor and IO interface in [0152] of Hastings into Toth for the purpose of providing a system to control a current flow from a battery to an electrode (as per [0152]), allowing for a control of a powering of an electrode via an I/O interface. While an electrode for therapy is present in Hastings, a switch to control sensory electrodes is implied in [0148]-[0149] with impedance sensing also present in [0129].
Regarding claim 50, Toth in view of Hunter teaches the system of claim 47, wherein Toth discloses the implantable medical device further comprises: a plurality of measurement circuits (plurality of sensory modules that may be impedance sensors in [0090]), each comprising a measurement line comprising one or more sensors (in figure 16 parts 1640a-f, where measurement lines can be defined from the top two sensors 1640a and 1640f, 1640e and 1640b, 1640d and 1640c), wherein the measurement lines are mounted in parallel (should lines be drawn between said sensors, they would be in parallel).
However, Toth does not teach a plurality of line selectors, wherein each line selector of the plurality of line selectors is associated with a respective measurement line and configured to control current supply to the respective measurement line.
Instead, Hastings does teach a plurality of line selectors (the switches in [0152] would act as line selectors), wherein each line selector of the plurality of line selectors is associated with a respective measurement line and configured to control current supply to the respective measurement line (the switch is configured to facilitate switching of components “to selectively charge the electrode arrangement” in [0091]. As such, the switch does control the power to the sensory electrode to charge it. This would allow for a selection of a measurement line in Toth to control a powering of one or more of the sensors of the measurement lines of Toth).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the switches with the microprocessor and IO interface in [0152] of Hastings into Toth for the purpose of providing a system to control a current flow from a battery to an electrode (as per [0152]), allowing for a control of a powering of an electrode via an I/O interface. While an electrode for therapy is present in Hastings, a switch to control sensory electrodes is implied in [0148]-[0149] with impedance sensing also present in [0129].
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth (US Pub No.: 2014/0081154) in view of Hunter (US Pub. No.: 2016/0310077) and Boyden (US Pub No.: 2008/0172073).
Regarding claim 42, Toth in view of Hunter teaches the apparatus of claim 35. However, Toth does not teach an instance further comprising: an hyperplasia-limiting coating on one or more of the plurality of impedance sensors.
Instead, Boyden (US Pub No.: 2008/0172073) discloses an instance further comprising: an hyperplasia-limiting coating on one or more of the plurality of impedance sensors (in [0144] and [0377], a coating to reduce neointimal hyperplasia is present). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a coating to reduce hyperplasia from Boyden into Toth for the purpose of preventing a hyperplasia that may be caused by a stent, which would be beneficial toward the device of Toth.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth (US Pub No.: 2014/0081154) in view of Hunter (US Pub. No.: 2016/0310077) and Stanley (US Pub No.: 2016/0077030).
Regarding claim 48, Toth in view of Hunter teaches the medical system of claim 47, wherein Toth discloses the implantable medical device further comprises: an antenna (in [0100]) to emit an electromagnetic field (as the antenna is disclosed as being “RF circuitry,” it is implied that the antenna will emit an electromagnetic field as per the definition of RF) according to an impedance of the measurement circuit (communication of sensed information in [0042], where the communication module of [0042] does comprise the antenna in [0044]). However, Toth does not teach an analogue/digital converter situated between the measurement circuit and the antenna.
Instead, Stanley (US Pub No.:2016/0077030) does teach an analog/digital converter (in [0050]) situated between the measurement circuit and the antenna (the converter of Stanley can be incorporated between a measurement circuit and antenna of Toth. Figures 1 and 5 of Stanley shows the converter 165 in a measurement circuit). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the analog to digital converter of Stanley into Barakat for the purpose of providing a means to convert a signal into Toth. As an EM field is being generated by a coil in the communication unit in [0172], a signal conversion between the sensors and the communication module is required to convert a sensed signal for said communication module.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth (US Pub No.: 2014/0081154) in view of Hunter (US Pub. No.: 2016/0310077) and Gelbart (US Pub No.: 2010/0010612).
Regarding claim 49, Toth in view of Hunter teaches the medical system of claim 47. However, Toth does not teach an instance wherein the measurement circuit further comprises: a resistor between two sensors of the one or more impedance sensors, wherein the resistor comprises a fixed impedance.
Instead, Gelbart (US Pub No.: 2010/0010612) does teach a resistor between two sensors of the one or more impedance sensors (Gelbart does teach resistors 24-28 as per [0018] in a sensor in figure 5. Here, as Toth discloses a plurality of sensors connected via flexible links 1650a-f of Toth, the resistors would be between the sensors of Toth), wherein the resistor comprises a fixed resistance (as the resistor is not disclosed to have a variable resistance (i.e. a potentiometer), the impedance across the resistor would remain constant in the circuits of figure 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the resistor details of Gelbart into Toth for the purpose of providing a means to modify a voltage applied to the sensory means in Toth (as per the known function of resistors and as detailed in [0018]). While a resistor is not mentioned in Toth, a resistor is required for the electrically powered sensors of Toth to operate.
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth (US Pub No.: 2014/0081154) in view of Hunter (US Pub. No.: 2016/0310077) and Najafi (US Pub No.: 2016/0183842).
Regarding claim 51, Toth in view of Hunter teaches the medical system of claim 47, wherein Toth discloses the computing device further comprises an antenna configured to emit an electromagnetic field to induce power in the measurement circuit (use of a communication module to drive an EM electrode in [0171] to emit an EM field).
However, Toth does not teach an instance wherein the emitted electromagnetic field would induce power in the measurement circuit.
Instead, Najafi (US Pub No.: 2016/0183842) does disclose using an electromagnetic field to induce power in the measurement circuit (in [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the EM power source and antenna to turn an electromagnetic signal into power as presented in Najafi into Toth for the purpose of providing a system to control a power delivery of the device of Toth via a remote system disclosed in [0033].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rajagopalan (US Pub No.: 2017/0007310) discloses a catheter device with an elongate shaft and a sensor on an interior wall in sensor part 139, disclosed in [0140] and figures 4A-4C.
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774