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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 10,743,812 to Glumac et al. (Glumac) (cited by applicant).
In reference to at least claim 1
Glumac discloses, an implantable auditory aid device (e.g. a middle ear implantable hearing aid system; column 1, lines 13-17), comprising: a piezoelectric sensor (e.g. a bi-element transducer 70 which may operate as either an Input or output transducer; column 7, lines 21-26); and a platform having an anchor to attach to a subject's ear bone and a support to hold the piezoelectric sensor such that the piezoelectric sensor is cantilevered (e.g. a mount 75 having a base, platform, secured to a temporal bone within the middle ear, and a portion, a support, at the proximal end of the transducer 70, the transducer cantilevered at its proximal end, and as the mount is attached to bone it will need to be anchored to stay in place; figure 2; column 7, lines 21-23); wherein the piezoelectric sensor comprises: a flex printed circuit board (e.g. further illustrated in the embodiment of figure 5, the transducer, now vibratory body 150, includes a central vane 154 comprising a conductive material, as the entire vibratory body 150 bends so does the central vane; figure 5; column 10, lines 5-14); a top sensor disposed on a first surface of the flex printed circuit board (e.g. a first piezoelectric body 152 on a first surface; figure 5; column 10, lines 5-14); and a bottom sensor disposed on an opposite second surface of the flex printed circuit board (e.g. a second piezoelectric body 156 on a second surface; figure 5; column 10, lines 5-14); the top sensor and bottom sensor made of a piezoelectric material (e.g. each of the first and second piezoelectric bodies made of a piezoelectric material).
Claim Rejections - 35 USC § 103
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac).
In reference to at least claim 2
Glumac discloses, the implantable auditory aid device of claim 1, wherein the top sensor and the bottom sensor are the same in a length direction as the flex printed circuit board and each have a proximal end near an attachment to the support and a distal end (e.g. the central vane 154 the same length as the piezoelectric bodies 152, 156, each having a proximal end near the mount 75, and a distal end; figure 5), wherein the distal end of one of the sensors is adapted to contact an umbo in the subject's ear (e.g. the distal end may be coupled to a tympanic membrane 30, or malleus 40; column 7, lines 21-30 ). Glumac fails to disclose, wherein the top sensor and the bottom sensor are shorter in a length direction than the flex printed circuit board. However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the central vane of the auditory device of Glumac such that the top sensor and the bottom sensor are shorter in a length direction than the flex printed circuit board, since such a modification would involve a mere change in size of a component, see MPEP 2144.04, and would have yielded the predictable result of providing easier access to connect leads to the central vane by allowing it to extend further than the piezoelectric bodies.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US 2012/0053393 A1 to Kaltenbacher et al. (Kaltenbacher) (cited by applicant).
In reference to at least claim 3
Glumac renders obvious the implantable auditory aid device of claim 2. However, Glumac fails to disclose, wherein the proximal end is wider than the distal end.
Kaltenbacher discloses, an in ear sound transducer, wherein the proximal end is wider than the distal end (e.g. a sound transducer having a piezo electric layer 2 above a carrier layer 1 split into eight or more individual segments 9a, 9b connected to an edge 6, at a proximal end, the proximal end of each segment wider than a distal end; figures 2A-2C; paragraphs [0073]-[0076]).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that the proximal end is wider than the distal end, as taught by Kaltenbacher, in order to provide a stronger connection over a larger area at the proximal end.
In reference to at least claim 4
Glumac modified by Kaltenbacher renders obvious, the implantable auditory aid device of claim 3. Kaltenbacher further discloses wherein a top sensor is shaped as a triangle, trapezoid or pentagon (e.g. the individual segments 9a, 9b are 'cake shaped', i.e. triangular or trapezoidal; figure 2C; paragraph [0075]). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that the top sensor and the bottom sensor are each shaped as a triangle, trapezoid or pentagon, as taught by Kaltenbacher, in order to provide a stronger connection over a larger area at the proximal end.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US 2012/0053393 A1 to Kaltenbacher et al. (Kaltenbacher) as applied to claim 3 further in view of CN107819410 to Gao et al. (Gao) (cited by applicant).
In reference to at least claim 5
Glumac modified by Kaltenbacher renders obvious, the implantable auditory aid device of claim 3. However, Glumac fails to disclose, wherein the top sensor and the bottom sensor are each shaped as a hexagon.
Gao discloses, a piezoelectric energy collector, wherein a sensor is shaped as a hexagon (e.g. flexible PCBs 210 and 220 are disposed on either side of a layer of piezoelectric ceramic pieces 230, each piezoelectric ceramic piece shaped as a regular shape such as a hexagon; figure 3; paragraphs [0031]-[0036]).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac modified by Kaltenbacher such that the sensors are shaped as hexagons, as taught by Gao in order to improve the sensitivity, as well as prevent voltage defects around the resonant frequency of a vibrating piezoelectric body (‘410, paragraph [0005]).
Claim(s) 6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of CN 113497177 to Yang et al. (Yang) (cited by applicant).
In reference to at least claim 6
Glumac renders obvious the implantable auditory aid device of claim 2. However, Glumac fails to disclose, wherein silver epoxy is disposed between the top sensor and the first surface of the flex printed circuit board to form a positive electrode; silver epoxy is disposed between the bottom sensor and the opposite second surface of the flex printed circuit board to form a negative electrode; and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board.
Yang discloses, a vibration sensor, wherein silver epoxy is disposed between a sensor and the first surface of the flex printed circuit board to form a positive electrode (e.g. a vibration sensor includes a PVDF film 5, connected to a first electrode 2 on a first side of the vibration sensor via a conductive silver adhesive, the first electrode connected to a third electrode 4 to extract the charge signal on one side of the PVDF film 5, i.e. one of a positive and negative signal; paragraphs [0039], [0041],[0050] ); silver epoxy is disposed between the sensor and the opposite second surface of the flex printed circuit board to form a negative electrode (e.g. the PVDF film connected to a second electrode on a second side via a conductive silver adhesive to extract the charge signal on the other side of the PVDF film, i.e. a positive or negative electrode; paragraphs [0042], [0050]); and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board (e.g. the second an third electrodes connected to terminals 9, and 7 respectively; figure 3).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that silver epoxy is disposed between the top sensor and the first surface of the flex printed circuit board to form a positive electrode; silver epoxy is disposed between the bottom sensor and the opposite second surface of the flex printed circuit board to form a negative electrode; and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board, as taught by Yang, in order to provide a device without rigid electrical connections that can be freely bent or folded without damaging the piezoelectric components (e.g. ‘177, paragraph [0031]).
In reference to at least claim 8
Glumac modified by Yang renders obvious, the implantable auditory aid device of claim 6. Glumac further discloses wherein signals from the positive electrode and the negative electrode are used as inputs to a differential amplifier (e.g. “ After processing and amplification,” therefore the signals from sensor leads are processed and amplified, by an amplifier; column 8, lines 45-52).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of CN 113497177 to Yang et al. (Yang) as applied to claim 6 further in view of US Patent No. 5,166,573 to Brown (Brown).
In reference to at least claim 7
Glumac modified by Yang renders obvious, the implantable auditory aid device of claim 6. However, Glumac fails to disclose, wherein an exposed surface of the top sensor and the exposed surface of the bottom sensor are covered with a conductive coating, which serves as a ground plane and is connected to a ground pad on the flex printed circuit board.
Brown discloses, an ultrasound transducer, wherein an exposed surface of the top sensor and the exposed surface of the bottom sensor are covered with a conductive coating (e.g. an ultrasound transducer 14 including an unpoled polymeric film layer 24 and a piezo film layer 20 separated by a metallic layer 28, on outer surfaces 34, 36 of the layers 24, 20 are .shielding electrodes 26, 22; figure 3; column 4, lines 43-64), which serves as a ground plane and is connected to a ground pad on the flex printed circuit board (e.g. the shield layers protecting from electromagnetic interference, and connected to the ground 42 of a cable 18; figures 3-4; column 4, lines 61-64; column 7, lines 5-28).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac modified by Yang such that an exposed surface of the top sensor and the exposed surface of the bottom sensor are covered with a conductive coating, which serves as a ground plane and is connected to a ground pad on the flex printed circuit board as taught by Brown in order to reduce the susceptibility of the transducer to electromagnetic interference (‘573, column 4, lines 61-64).
Claim(s) 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US 2019/0379300 to Cao et al. (Cao).
In reference to at least claim 9
Glumac renders obvious the implantable auditory aid device of claim 2. However, Glumac fails to disclose, wherein a conductive layer is evaporated on the first surface of the flex printed circuit board to form a positive electrode and the conductive layer is evaporated on the opposite second surface of the flex printed circuit board to form a negative electrode; wherein the top sensor and the bottom sensor are each attached to the conductive layer using an adhesive and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board.
Cao discloses, an energy generating device, wherein a conductive layer is evaporated on the first surface the flex printed circuit board to form a positive electrode and the conductive layer is evaporated on the opposite second surface of the flex printed circuit board to form a negative electrode (e.g. an energy generating device includes a substrate 10 with energy generating components 20, piezoelectric PDMS impregnated PVDF fibers, mounted on the top and bottom, the energy generating components including electrical contact layers 75 on each side comprising a PET substrate with an evaporated electrode film; figures 7-8F; paragraphs [0015], [0021],[0036]-[0038]); wherein the top sensor and the bottom sensor are each attached to the conductive layer using an adhesive and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board (e.g. the electrodes and PVDF are adhered by curing the PDMS, and are connected at electrical connection points 70 of the device; paragraph [0021], [0038]).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that a conductive layer is evaporated on the first surface of the flex printed circuit board to form a positive electrode and the conductive layer is evaporated on the opposite second surface of the flex printed circuit board to form a negative electrode; wherein the top sensor and the bottom sensor are each attached to the conductive layer using an adhesive and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board, as taught by Cao, in order to provide a resilient device capable of deformation and recovery in three orthogonal directions (‘300, paragraph [0006]).
In reference to at least claim 11
Glumac modified by Cao renders obvious a the implantable auditory aid device of claim 9. Glumac further discloses, wherein signal from the positive electrode and the negative electrode are used as inputs to a differential amplifier (e.g. “After processing and amplification,” therefore the signals from sensor leads are processed and amplified, by an amplifier; column 8, lines 45-52).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US 2019/0379300 to Cao et al. (Cao) as applied to claim 9 further in view of US Patent No. 5,166,573 to Brown (Brown).
In reference to at least claim 10
Glumac modified by Cao renders obvious a the implantable auditory aid device of claim 9. However, Glumac fails to disclose, wherein an exposed surface of the top sensor and the exposed surface of the bottom sensor are covered with a conductive coating, which serves as a ground plane and is connected to the flex printed circuit board.
Brown discloses, wherein an exposed surface of the top sensor and the exposed surface of the bottom sensor are covered with a conductive coating (e.g. an ultrasound transducer 14 including an unpoled polymeric film layer 24 and a piezo film layer 20 separated by a metallic layer 28, on outer surfaces 34, 36 of the layers 24, 20 are shielding electrodes 26, 22; figure 3; column 4, lines 43-64), which serves as a ground plane and is connected to the flex printed circuit board (e.g. the shield layers protecting from electromagnetic interference, and connected to the ground 42 of a cable 18; figures 3-4; column 4, lines 61-64; column 7, lines 5-28).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac modified by Cao such that an exposed surface of the top sensor and the exposed surface of the bottom sensor are covered with a conductive coating, which serves as a ground plane and is connected to the flex printed circuit board, as taught by Brown, in order to reduce the susceptibility of the transducer to electromagnetic interference (‘573, column 4, lines 61-64).
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US 2022/0014120 to Andosca et al. (Andosca).
In reference to at least claim 12
Glumac renders obvious the implantable auditory aid device of claim 2. However, Glumac fails to disclose, wherein a conductive layer is sputtered on the first surface of the flex printed circuit board to form a positive electrode and the conductive layer is sputtered on the opposite second surface of the flex printed circuit board to form a negative electrode; wherein the top sensor and the bottom sensor are each attached to the conductive layer using an adhesive and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board.
Andosca discloses, a transducer, wherein a conductive layer is sputtered on the first surface of the flex printed circuit board to form a positive electrode and the conductive layer is sputtered on the opposite second surface of the flex printed circuit board to form a negative electrode (e.g. transducers 104 include a substrate 302, on each side is a sputter deposited molybdenum electrode 304-1A, 304-1 B; figure 3A; paragraphs [0084]-[0086]); wherein the top sensor and the bottom sensor are each attached to the conductive layer using an adhesive and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board (e.g. adhered to the electrodes 304-1A, 304-1 Bare piezoelectric layers 306A and 306B respectively, the electrodes electrically connected by an adhesion layer AL1, AL2 to the substrate 302; paragraphs [0084]-[0087]).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that a conductive layer is sputtered on the first surface of the flex printed circuit board to form a positive electrode and the conductive layer is sputtered on the opposite second surface of the flex printed circuit board to form a negative electrode; wherein the top sensor and the bottom sensor are each attached to the conductive layer using an adhesive and the positive electrode and the negative electrode are connected to pads on the flex printed circuit board, as taught by Andosca, in order to improve adhesion and electrical connectivity between the various layers of the transducer (‘120, paragraphs [0086]-[0087]).
In reference to at least claim 14
Glumac modified by Andosca renders obvious the implantable auditory aid device of claim 12. Glumac further discloses wherein signals from the positive electrode and the negative electrode are used as inputs to a differential amplifier (e.g. “After processing and amplification,” therefore the signals from sensor leads are processed and amplified, by an amplifier; column 8, lines 45-52).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US 2022/0014120 to Andosca et al. (Andosca) as applied to claim 12 further in view of US Patent No. 5,166,573 to Brown (Brown).
In reference to at least claim 13
Glumac modified by Andosca renders obvious the implantable auditory aid device of claim 12. However, Glumac fails to disclose, wherein an exposed surface of the top sensor and the exposed surface of the bottom sensor are sputtered with a conductive coating, which serves as a ground plane and is connected to the flex printed circuit board using a conductive ink.
Brown discloses, wherein an exposed surface of the top sensor and the exposed surface of the bottom sensor are sputtered with a conductive coating (e.g. an ultrasound transducer 14 including an unpoled polymeric film layer 24 and a piezo film layer 20 separated by a metallic layer 28, on outer surfaces 34, 36 of the layers 24, 20 are shielding electrodes 26, 22; figure 3; column 4, lines 43-64 ), which serves as a ground plane and is connected to the flex printed circuit board using a conductive ink (the shield layers protecting from electromagnetic interference, and connected to the ground 42 of a cable 18, and are applied using silkscreened conductive ink; figures 3-4; column 4, lines 61-64; column 6, lines 41-67; column 7, lines 5-28).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac modified by Andosca such that an exposed surface of the top sensor and the exposed surface of the bottom sensor are sputtered with a conductive coating, which serves as a ground plane and is connected to the flex printed circuit board using a conductive ink as taught by Brown, in order to reduce the susceptibility of the transducer to electromagnetic interference (‘573, column 4, lines 61-64).
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US Patent No. 6,325,755 to Bushek et al. (Bushek) (cited by applicant).
In reference to at least claim 15
Glumac discloses, the implantable auditory aid device of claim 1. However, Glumac fails to disclose, wherein the platform comprises: the anchor, for attachment to the subject's ear bone; and the support disposed at a distal end of an arm; wherein the anchor and the support are separate components.
Bushek discloses, wherein the platform comprises: the anchor, for attachment to the subject's ear bone (e.g. a support assembly 10 comprises a mounting flange 145 mounted against a mastoid 34; figure 3; column 10, lines 54-55; column 11, lines 1-5 ); and the support disposed at a distal end of an arm (a transducer support 160 mounted at the end of a transducer assembly 168 and sleeve 135; figure 3; column 11, lines 35-41 ); wherein the anchor and the support are separate components (the mounting flange and support are separate components; figure 3).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention lo have modified the device of GLUMAC such that the platform comprises: the anchor, for attachment to the subject' s ear bone; and the support disposed at a distal end of an arm; wherein the anchor and the support are separate components as taught by Bushek. The motivation would have been to facilitate efficient and accurate positioning of a transducer or sensor (‘755, column 3,lines 9-13).
In reference to at least claim 16
Glumac modified by Bushek renders obvious the implantable auditory aid device of claim 15. Bushek further discloses a ball joint disposed on the anchor and a ball disposed on a proximal end of the arm (e.g. a hanger 150 accepts a ball end of the sleeve 135 at the proximal end of the sleeve forming a ball and socket joint; figure 3; column 11, lines 36-38), wherein the arm is rigidly attached to the ball joint using a set screw (the sleeve 135 attached to the hanger 150 with a retaining nut 120 with external threads; figure 3; column 11, lines 36-38). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac to include a ball joint disposed on the anchor and a ball disposed on a proximal end of the arm, wherein the arm is rigidly attached to the ball joint using a set screw, as taught by Bushek, in order to facilitate efficient and accurate positioning of a transducer or sensor (‘755, column 3, lines 9-13).
In reference to at least claim 17
Glumac modified by Bushek renders obvious the implantable auditory aid device of claim 15. Bushek further discloses wherein the anchor comprises one or more anchor holes (e.g. the mounting flange 145 including apertures 142; figure 3; column 11, lines 28-31 ), and the ball joint comprises a threaded hole (e.g. the hanger of the ball and socket joint including hanger threads 157 designed to accept the retaining nut; column 11, lines 44-48). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that the anchor comprises one or more anchor holes, and the ball joint comprises a threaded hole as taught by Bushek in order to facilitate efficient and accurate positioning of a transducer or sensor (‘755, column 3, lines 9-13).
In reference to at least claim 18
Glumac modified by Bushek renders obvious the implantable auditory aid device of claim 17. Bushek further discloses, a method of implanting the implantable auditory aid device in the subject’s ear, comprising: attaching the anchor to a bone in a mastoid cavity by inserting screws through the one or more anchor holes (e.g. positioning the flange 145 against mastoid 34, attached with bone screws; column 11, lines 18-31 ); guiding the piezoelectric sensor through a facial recess of the subject, while the piezoelectric sensor is attached to the support (e.g. the transducer 162 attached to the support 160 is inserted into a facial recess 15; figures 11-13; column 13, lines 22-29); and affixing the arm to the anchor by tightening a set screw in the threaded hole (e.g. attaching the sleeve to the hanger, and therefore the mounting flange, by engaging it with the retaining nut 120; column 11, lines 46-55). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Glumac to include attaching the anchor to a bone in a mastoid cavity by inserting screws through the one or more anchor holes; guiding the piezoelectric sensor through a facial recess of the subject, while the piezoelectric sensor is attached to the support; and affixing the arm to the anchor by tightening a set screw in the threaded hole, as taught by Bushek, in order to efficiently and accurately position a transducer or sensor (‘755, column 3, lines 9-13).
In reference to at least claim 19
Glumac modified by Bushek renders obvious the method of claim 18. Bushek further discloses wherein after tightening the set screw, the piezoelectric sensor contacts an umbo (e.g. once engaged in a socket 152 of the hanger 150 and locked in place by the nut 120, the transducer can be properly positioned against a bone of the ossicular chain, such as the umbo; column 12, lines 1-10). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the method of Glumac modified such that after tightening the set screw, the piezoelectric sensor contacts an umbo, as taught by Busheck, in order to efficiently and accurately position a transducer or sensor (‘755, column 3, lines 9-13).
In reference to at least claim 20
Glumac modified by Bushek renders obvious the method of claim 18. Bushek further discloses inserting the set screw in the threaded hole prior to guiding the piezoelectric sensor (e.g. as the sleeve 135 is only locked in place when the nut 120 is engaged with the threads it can be inserted at any time; column 11, lines 50-55).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US Patent No. 6,325,755 to Bushek et al. (Bushek) as applied to claim 19 further in view of CN 112401819 to Wei et al. (Wei) (cited by applicant).
In reference to at least claim 21
Glumac modified by Bushek renders obvious the method of claim 19. However, Glumac fails to disclose, the positioning of the piezoelectric sensor is confirmed using an endoscope.
Wei discloses, wherein the positioning of the piezoelectric sensor Is confirmed using an endoscope (e.g. an auxiliary examination device for artificial ossicle installation is used to determine its relative position; paragraphs [0008], [0010]).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the method of Glumac modified by Bushek such that, the positioning of the piezoelectric sensor is confirmed using an endoscope as taught by Wei in order to ensure the device is positioned properly so that it will properly sense vibrations in a subject's ear (‘819, para. [0010]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US Patent No. 6,325,755 to Bushek et al. (Bushek) as applied to claim 19 further in view of WO 2021/191699 to Waldmann (Waldmann) (cited by applicant).
In reference to at least claim 22
Glumac modified by Bushek renders obvious the method of claim 19. However, Glumac fails to disclose, wherein the positioning of the piezoelectric sensor is confirmed by delivering a sound to an ear canal and monitoring an output of the piezoelectric sensor.
Waldmann discloses, wherein the positioning of the piezoelectric sensor is confirmed by delivering a sound to an ear canal and monitoring an output of the piezoelectric sensor (e.g. relating the position of an implanted vibration sensor to the signal received by the sensor; paragraph [0021]).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the method of Glumac modified by Bushek such that the positioning of the piezoelectric sensor is confirmed by delivering a sound to an ear canal and monitoring an output of the piezoelectric sensor as taught by Waldmann in order to determine whether the sensor is in a suitable location without the need for external means.
Claim(s) 23-24 and 26-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of JP 2007287910 to Watabe et al. (Watabe) (cited by applicant).
In reference to at least claim 23
Glumac discloses, the implantable auditory aid device of claim 1. However, Glumac fails to disclose, wherein the top sensor comprises a first plurality of piezoelectric layers stacked on the first surface of the flex printed circuit board; and the bottom sensor comprises a second plurality of piezoelectric layers stacked on the opposite second surface of the flex printed circuit board.
Watabe discloses, a piezoelectric bimorph element, wherein the top sensor comprises a first plurality of piezoelectric layers stacked on the first surface of the flex printed circuit board (e.g. a top piezoelectric ceramic element 21 includes a multiple layers of piezoelectric material stacked with internal electrodes on one side of an elastic plate 22; figure 2b; paragraph [0024]-[0028], [0028]); and the bottom sensor comprises a second plurality of piezoelectric layers stacked on the opposite second surface of the flex printed circuit board (e.g. the bottom element 21 the same as the top; figure 2b).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Glumac such that the top sensor comprises a first plurality of piezoelectric layers stacked on the first surface of the flex printed circuit board; and the bottom sensor comprises a second plurality of piezoelectric layers stacked on the opposite second surface of the flex printed circuit board, as taught by Watabe, in order to provide a piezoelectric element with higher sensitivity, as less pressure or strain is required for a given voltage (‘910, paragraph [0002]).
In reference to at least claim 24
Glumac modified by Watabe renders obvious the implantable auditory aid device of claim 23. Watabe further discloses a conductive layer is disposed on both surfaces of each piezoelectric layer, wherein the conductive layers serve as electrodes or ground layers (e.g. each layer having an electrode paste pattern printed on one side, and is in contact with the electrode of an adjacent layer; paragraphs [0004], [0026]-[0028]). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that a conductive layer is disposed on both surfaces of each piezoelectric layer, wherein the conductive layers serve as electrodes or ground layers as taught by Watabe in order to provide a piezoelectric element with higher sensitivity, as less pressure or strain is required for a given voltage (‘910, paragraph [0002]).
In reference to at least claim 26
Glumac modified by Watabe renders obvious the implantable auditory aid device of claim 24. Watabe further discloses wherein the conductive layer on a first surface of a piezoelectric layer is also the conductive layer on a second surface of an adjacent piezoelectric layer, and a conductive epoxy is used to affix the piezoelectric layer and the adjacent piezoelectric layer (e.g. each layer having an electrode paste pattern printed on one side, and is in contact with the electrode of an adjacent layer, the layers are sintered and laminated, the electrode paste along with an organic binder forming a conductive adhesive, paragraphs [0004], [0026]-[0028]). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that the conductive layer on a first surface of a piezoelectric layer is also the conductive layer on a second surface of an adjacent piezoelectric layer, and a conductive epoxy is used to affix the piezoelectric layer and the adjacent piezoelectric layer, as taught by Watabe, in order to provide an electrical connection between each layer.
In reference to at least claim 27
Glumac modified by Watabe renders obvious the implantable auditory aid device of claim 24. Watabe further discloses an epoxy disposed between the conductive layer on a first surface of a piezoelectric layer and the conductive layer on a second surface of an adjacent piezoelectric layer (e.g. each layer having an electrode paste pattern printed on one side, and is in contact with the electrode of an adjacent layer, the layers are sintered and laminated, the electrode paste along with an organic binder forming a conductive adhesive, paragraphs [0004], [0026]-[0028]). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that an epoxy is disposed between the conductive layer on a first surface of a piezoelectric layer and the conductive layer on a second surface of an adjacent piezoelectric layer, as taught by Watabe, in order to ensure all the piezoelectric layers adhere to one another.
In reference to at least claim 28
Glumac modified by Watabe renders obvious the implantable auditory aid device of claim 23. Watabe further discloses, wherein the first plurality of piezoelectric layers is equal to the second plurality of piezoelectric layers (e.g. the ceramic elements 21 are the same; figure 2b). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that the first plurality of piezoelectric layers is equal to the second plurality of piezoelectric layers, as taught by Watabe, in order to provide an equal signal from each side.
Claim(s) 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,743,812 to Glumac et al. (Glumac) in view of US 2010/02968626 to Andersson et al. (Anderson) (cited by applicant).
In reference to at least claim 23
Glumac discloses, the implantable auditory aid device of claim 1. However, Glumac fails to disclose, wherein the top sensor comprises a first plurality of piezoelectric layers stacked on the first surface of the flex printed circuit board; and the bottom sensor comprises a second plurality of piezoelectric layers stacked on the opposite second surface of the flex printed circuit board.
Andersson discloses, a multilayer piezoelectric element, wherein the top sensor comprises a first plurality of piezoelectric layers stacked on the first surface of the flex printed circuit board (e.g. piezoelectric layers 402B, 402A arranged on a first side of a passive layer 404; figure 4A); and the bottom sensor comprises a second plurality of piezoelectric layers stacked on the opposite second surface of the flex printed circuit board (e.g. piezoelectric layers 402C, 402D on the opposite side of the passive layer 404; figure 4A). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the device of Glumac such that the top sensor comprises a first plurality of piezoelectric layers stacked on the first surface of the flex printed circuit board; and the bottom sensor comprises a second plurality of piezoelectric layers stacked on the opposite second surface of the flex printed circuit board, as taught by Andersson, in order to provide greater sensitivity, since the output voltage of a multilayer piezoelectric element will be greater for a lesser input (‘626, paragraph [0030]).
In reference to at least claim 24
Glumac modified by Andersson renders obvious the implantable auditory aid device of claim 23. Andersson further discloses, wherein a conductive layer is disposed on both surfaces of each piezoelectric layer, wherein the conductive layers serve as electrodes or ground layers (e.g. each of the piezoelectric layers having electrodes, they will need to be in contact with each layer to apply a charge; paragraph [0045]). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that a conductive layer is disposed on both surfaces of each piezoelectric layer, wherein the conductive layers serve as electrodes or ground layers, as taught by Andersson, in order to provide or receive a charge from each layer.
In reference to at least claim 25
Glumac modified by Andersson renders obvious the implantable auditory aid device of claim 23. Andersson further discloses, wherein outputs from the electrodes disposed on the first surface of the flex printed circuit board are arranged in parallel such that charges induced on each of the first plurality piezoelectric layers are summed (e.g. when an electric field is applied to the piezoelectric element, the output of those disposed on the first surface are in the same direction , summed; figure 48; paragraph [0045]). It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have further modified the device of Glumac such that wherein outputs from the electrodes disposed on the first surface of the flex printed circuit board are arranged in parallel such that charges induced on each of the first plurality of piezoelectric layers are summed as taught by Andersson in order to provide greater sensitivity, since the output voltage of a multilayer piezoelectric element will be greater for a lesser input (‘626, paragraph [0030]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2016/0287870 to Yip et al. which teaches a low power cochlear implant. US 2024/0050745 to Kulah et al. which teaches a MEMs-based cochlear implant.
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