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 .
Status of Claims
This Office Action is responsive to the claims filed on 01/16/2026. Claims 1, 12, 20, and 25-27 have been amended. Claims 4, 6, 18, and 23 were previously canceled. Claims 1-3, 5, 7-17, 19-22, and 24-27 are presently pending in this application.
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.
Claims 1, 3, 5, 7-10, 12, 19, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi (US 20210128106) in view of Dausch (US 20100168583),Yang (CN-115568919-A, translation of CN-115568919-A relied upon herein).
Regarding claim 1, Salehi, teaches an ultrasonic imaging system (Paragraph [0006]; tubular shaft and an ultrasonic transducer array; Paragraph [0046]; medical system 10, Fig. 1) comprising:
an Intracardiac echocardiography (ICE) catheter (Paragraphs [0046] and [0051]; introducer sheath 12 and ultrasound transducer 40, Fig. 1) having a longitudinal axis (Paragraph [0056]; longitudinal axis 60, Fig. 2B), a proximal end (Paragraph [0049]; proximal end 34, Fig. 1), and a distal end (Paragraph [0049]; distal end 36, Fig. 1);
a transducer ring positioned at the distal end of the ICE catheter (Paragraph [0057]; transducer array 40; ultrasound transducers 70 arranged in a circular pattern, Fig. 2A), wherein the transducer ring comprises a Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) array (Paragraph [0074]; the ultrasound transducers 70 can be piezoelectric micromachined ultrasound transducers (PMUTs)), wherein the pMUT array is a forward facing assembly (Paragraph [0065]; ultrasound transducers 70 in a direction that oblique with respect to the longitudinal axis… providing a substantially forward-directed field-of-view of the ultrasound image, Fig. 2A), and
comprises a plurality of pMUT array elements (Paragraph [0072]; ultrasound transducers 70 arranged in a circular array about the longitudinal axis 60, Fig. 2A);
a steerable sheath (Paragraph [0063]; sheath 12 includes a steering wire 80 can be manipulated by the user to deflect the distal region of the shaft 32, Fig. 2B) integrated with a built-in forward looking transducer (Paragraph [0065]; ultrasound transducers 70 are disposed within the shaft wall 66… substantially forward-directed) and the transducer ring positioned at the distal end of the ICE catheter (Paragraph [0058]; ultrasonic transducer array 40 is a circular array, Fig. 2A);
a catheter shaft (Paragraph [0049]; sheath 12 includes a shaft 32) connected at one end to a handle assembly (Paragraph [0049]; a handle mechanism 38 attached to the proximal end 34) and at other end to the pMUT array (Paragraph [0051]; an ultrasonic transducer array 40 at the distal end 36 of the shaft 32), wherein the catheter shaft houses an open ended lumen (Paragraph [0056]; shaft lumen 39, Fig. 2A; Figs. 1 and 2 show the lumen is open ended.) that is configured to allow a passage of a puncture needle (Paragraph [0067]; medical introducer sheath 12… assist in the transseptal puncture procedure; typically by passing a needle through a dilator lumen and across the septum) and an electronic flex cable towards the proximal end of the ICE catheter (Paragraph [0076]; electrical conductors 74; electrical conductors 74 can be strung through the conductor lumens, Fig. 2B), the electronic flex cable is in communication with at least one signal trace (Paragraph [0076]; electrical connection of the ultrasound transducers 70 to the ultrasound imaging module 50 can be accomplished via flexible circuits; Fig. 2B), and is configured to:
direct the pMUT array, via the at least one signal trace, to transmit and receive, with respect to heart, ultrasound beams (Paragraph [0055]; introducer sheath 12 is able to transmit and receive ultrasonic signals; Paragraph [0053], [0080]; the ultrasonic images generated from the ultrasound signals… within the heart; Intra-cardiac imaging; Paragraph [0077]; ultrasound transducers 70 to the ultrasound imaging module 50 can be accomplished via flexible circuits);
receive at least one signal from the pMUT array based on transmitting and receiving at least one ultrasound beam of the ultrasound beams (Paragraph [0053]; The imaging signals received back from the ultrasonic transducer array 40);
and construct at least one image of at least a portion of the heart based on the at least one signal (Paragraph [0053]; the ultrasonic images generated from the ultrasound signals… within the heart; Paragraph [0080]; ultrasound imaging module 50 can operate as intra-cardiac imaging system for 3D visualization of the heart chamber).
Salehi does not explicitly teach the transducer ring comprises a substrate and the Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) array is based on a micro-electromechanical system (MEMS); and
that the plurality of PMUT array elements are mounted in a linear fashion;
and the catheter shaft is configured to allow passage of an electronic flex cable.
Dausch, however, teaches an ultrasonic imaging system (Paragraph [0026]; medical ultrasound diagnostic imaging probes) comprising:
an Intracardiac echocardiography (ICE) catheter (Paragraph [0096]; three-dimensional intracardiac imaging catheter) having a longitudinal axis (Fig. 12, length of the catheter), a proximal end (Paragraph [0095]; Fig. 12, portion of catheter near mechanism 505), and a distal end (Paragraph [0094]; Fig. 12, portion of catheter with opening 513);
a transducer positioned at the distal end of the ICE catheter (Paragraph [0094]; pmut device 990, Fig. 12), wherein the transducer comprises a substrate (Paragraph [0060]-[0062]; substrate 12, Figs. 4-6) and a micro-electromechanical (MEMS) based Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) array (Paragraphs [0012] and [0027]; MEMS-type medical device is in imaging devices; "microfabricated," "micromachining" and "MEMS" are used interchangeably; Paragraphs [0037]; microfabricated piezoelectric elements; Paragraph [0040]; array of piezoelectric elements… pmut elements in the array) arranged over the substrate (Paragraph [0062]; form the pMUT element shape 22 on substrate 12, Fig. 5), wherein the MEMS based pMUT array is a forward facing assembly (Paragraph [0085]; forward viewing imaging catheter device), and
comprises a plurality of pMUT array elements mounted on the substrate (Paragraph [0062]; pmut elements 22 on substrate 12; Patterning of the pMUT device structure 100);
and an electronic flex cable towards the proximal end of the ICE catheter (Paragraph [0085]; catheter device 500 includes associated pMUT 90 integrated with flex cable 507, Fig. 9; Paragraph [0088]; flex cable can be routed through the catheter body and connected through the I/O connector at the back end of the catheter to external control circuitry), the electronic flex cable is in communication with at least one signal trace (Paragraph [0084]; pMUT device 90 may be bonded to a flex cable 507), and is configured to:
direct the MEMS based pMUT array, via the at least one signal trace, to transmit and receive, with respect to heart, ultrasound beams (Paragraph [0042]; bipolar transmit voltage is applied to the pMUT to emit acoustic energy… and returns toward the pMUT).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transducer array of Salehi to have comprised a substrate and be based on a micro-electromechanical system (MEMS) as taught by Dausch because the use of MEMS technology allows medical devices or their components to be manufactured with significant size reduction, especially in particular areas where miniaturized devices are desirable and where MEMS devices are attractive such as intravascular imaging (Dausch, Paragraphs [0004] and [0012]) and further improve the transducer by enhancing the sensitivity of the PMUT elements (Dausch, Paragraph [0026]).
Together Salehi and Dausch further fails to teach that the plurality of PMUT array elements are mounted in a linear fashion and the catheter shaft is configured to allow passage of an electronic flex cable.
Yang, however, teaches an ultrasonic imaging system (Pg. 2, Technical field; an ultrasonic guide
catheter and a puncture system of ultrasonic guidance; Fig. 1) comprising a transducer ring (Pg. 14, Embodiment 6, para. 2; the ultrasonic transducer of all the fan-shaped areas can form a larger transducer array, by ultrasonic phased array technology; Fig. 21) positioned at the distal end of the catheter (Pg. 14, Embodiment 6, para. 2; the carrier 2 is a trumpet-shaped structure set on the distal end of the catheter and can be folded in the sleeve structure 10, please refer to FIG. 19-21, the carrier 2 is a horn-shaped structure, the ultrasonic imaging assembly further comprises a supporting piece for supporting 11; Figs. 19-21);
wherein the plurality of PMUT array elements are mounted in a linear fashion (Fig. 21 shows the elements are arranged in arrays arranged tangentially around the shaft in linear fashion);
and the catheter shaft is configured to allow passage of an electronic flex cable (Pg. 12, full para. 2; , the cable 6 is a flexible cable, at the retracted position, the connection part of the cable 6 located
in the carrier 2 and the catheter main body is located between the carrier 2 and the catheter body 1, in the process of the carrier 2 around the hinge 5 to rotate, the part of the flexible cable 6 can be turned a certain angle, ensuring the transducer unit 3 connected with the main machine, as shown in FIG. 3, 4; Pg. 14, Embodiment 6, para. 4; the flexible circuit, transducer is directly arranged on the sheet of the high elasticity, The method can be applied to the instrument with a certain requirement to the space structure. when the sleeve structure 10 moves to the distal end of the catheter body 1, high elastic wire is folded by the sleeve structure 10, the carrier 2 can be folded in the sleeve structure 10; Figs. 4, 20, and 21 show the shaft allows passage of the transducers which are connected to the flexible cable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the plurality of PMUT array elements of Salehi in view of Dausch to have been mounted in a linear fashion as taught by Yang because it would allow arrangement in fan shapes which could be individually excited and received from in different directions and thus enable a phased array configuration (Pg. 14, Para. 2). It further would have been obvious to have modified the catheter shaft to allow passage of an electronic flex cable as further taught by Yang because it further would have allowed the transducers to be foldable into the catheter body and thereby protect the transducers when not in use, and further allow the tissue structures in front of the distal end to be viewed when deployed (Pg. 14, Para. 1-4).
Regarding claim 3, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Salehi further teaches the transducer ring is configured to transmit ultrasound beams forward of the distal end of the ICE catheter (Paragraph [0065]; the ultrasound transducers 70 are disposed within the shaft wall 66 such that the emitting/receiving face 72 of each ultrasound transducer 70 is aligned with the distal wall face 68… providing a substantially forward-directed field-of-view, Fig. 2A).
Regarding claim 5, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Salehi does not explicitly teach the transducer ring corresponds to a linear transducer ring with the MEMS based pMUT array mounted over the substrate in the linear fashion.
Yang, however, further teaches the transducer ring corresponds to a linear transducer ring with the MEMS based pMUT array mounted over the substrate in the linear fashion (Fig. 21 shows the elements are arranged in arrays arranged around the shaft in linear fashion.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transducer ring of Salehi in view of Dausch, Yang, and Rehrig to have corresponded to a linear transducer ring with the MEMS based pMUT array mounted over the substrate in the linear fashion as taught by Yang because it would have been a well-known and understood rearrangement of forward facing ultrasound elements that further would allow each element to be individually excited and received from in different directions and thus enable a phased array configuration (Pg. 14, Para. 2).
Regarding claim 7, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Dausch further teaches the distal tip of the ICE catheter is coated with a material to provide electrical isolation and transmission of ultrasound signals (Paragraph [0072]; Polymer passivation layer 190 is deposited on the piezoelectric element; provides electrical and chemical insulation from fluid that may come in contact with the device surface during use and may also serves as an acoustic matching layer providing a lower acoustic impedance layer between the transducer face and the fluid; Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the distal tip of the ICE catheter of Salehi in view of Dausch and Yang to have been coated with a material to provide electrical isolation and transmission of ultrasound signals as taught by Dausch because it would provide electrical and chemical insulation from fluid that may come in contact with the device surface during use and further serve as an acoustic matching layer providing a lower acoustic impedance layer between the transducer face and the fluid (Dausch, Paragraph [0072]).
Regarding claim 8, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Salehi further teaches the ICE catheter corresponds to a mechanical flexible sheath (Paragraph [0063]; medical introducer sheath 12 includes a steering wire 80 attached to an anchor band 82 securely fixed to the shaft 32 proximate the distal end 36) with a marker band (Paragraph [0051]; a radiopaque marker 48, Fig. 2A), to allow passage into the heart (Paragraph [0050]; operator to control the advancement and configuration of the shaft 32 during use), and form a location on an X-ray image (Paragraph [0051]; the radiopaque marker 48 facilitates localization and tracking of the distal region of the medical introducer sheath 12 using conventional fluoroscopy).
Regarding claim 9, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Salehi further teaches the ICE catheter is coupled to an imaging device (Paragraph [0052]; the medical system 10 also includes an ultrasonic imaging module 50, Fig. 1) configured to communicate ultrasound transmit pulses and ultrasound receive waveforms between the imaging device and the ICE catheter (Paragraph [0053]; imaging module 50 includes an ultrasonic signal generator 54… configured to provide electrical signals for controlling the ultrasonic transducer array 40; Paragraph [0077]; electrical connection of the ultrasound transducers 70 to the ultrasound imaging module 50 can be accomplished via flexible circuits such as are known in the art).
Salehi does not explicitly teach a custom dongle.
Dausch, however, further teaches a custom dongle configured to communicate ultrasound transmit pulses and receive waveforms (Paragraphs [0088]-[0091]; I/O connector; Low voltage signals (3-5V) may be sent from the I/O connector to the integrated multiplexing and high voltage driver circuitry, and the drivers generate the higher transmit voltage through charge pumps and/or inductive transformers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Salehi in view of Dausch and Yang to have comprised a custom dongle because it would allow multiplexing the signals thus reduce the number of signal wires. Reducing the number of leads also reduces the crosstalk between elements (Dausch, Paragraph [0089]).
Regarding claim 10, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Salehi further teaches the catheter shaft encloses a plurality of individual electronic flex cables connected between the handle assembly and the MEMS based pMUT array (Paragraph [0076]; ultrasound transducers 70 and the electrical conductors 74 and the electrical conductors 74 may be integrally embedded in the shaft wall 66 during the manufacture of the shaft 32 using conventional manufacturing techniques… individual conductor lumens formed therein, and the ultrasound transducers 70 and the electrical conductors 74 and the electrical conductors 74 can be strung through the conductor lumens during the assembly of the medical introducer sheath 12).
Regarding claim 12, Salehi teaches an Intracardiac echocardiography (ICE) catheter (Paragraphs [0046] and [0051]; introducer sheath 12 and ultrasound transducer 40, Fig. 1) comprising:
a body (Paragraph [0046]; introducer sheath 12) with a longitudinal axis (Paragraph [0056]; longitudinal axis 60, Fig. 2B), a proximal end (Paragraph [0049]; proximal end 34), a distal end (Paragraph [0049]; distal end 36, Fig. 1) and an open-ended lumen extending along the longitudinal axis (Paragraph [0056]; shaft lumen 39, Fig. 2A; Figs. 1 and 2 show the lumen is open ended.) :
a transducer ring positioned at the distal end of the ICE catheter (Paragraph [0057]; transducer array 40; ultrasound transducers 70 arranged in a circular pattern, Fig. 2A), wherein the transducer ring comprises a Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) array (Paragraph [0074]; the ultrasound transducers 70 can be piezoelectric micromachined ultrasound transducers (PMUTs)), wherein the pMUT array is a forward facing assembly (Paragraph [0065]; ultrasound transducers 70 in a direction that oblique with respect to the longitudinal axis… providing a substantially forward-directed field-of-view of the ultrasound image, Fig. 2A), and
comprises a plurality of transducer array elements (Paragraph [0072]; ultrasound transducers 70 arranged in a circular array about the longitudinal axis 60, Fig. 2A);
a steerable sheath (Paragraph [0063]; sheath 12 includes a steering wire 80 can be manipulated by the user to deflect the distal region of the shaft 32, Fig. 2B) integrated with a built-in forward looking transducer (Paragraph [0065]; ultrasound transducers 70 are disposed within the shaft wall 66… substantially forward-directed) and the transducer ring positioned at the distal end of the ICE catheter (Paragraph [0058]; ultrasonic transducer array 40 is a circular array, Fig. 2A), wherein
each transducer array element comprises a plurality of transducers (Paragraph [0021]; transducer array includes a plurality of ultrasound transducers), with a first group of two or more transducers in a first transducer array element (Paragraph [0058]; other embodiments, the ultrasonic transducer array 40 may include two or more rings of ultrasound transducers 70) and a
second group of two or more transducers in the first transducer array element (Paragraph [0058]), and each transducer array element is connected in parallel (Paragraph [0059]; Each of the electrical conductors 74 is electrically connected to a respective one of the ultrasound transducers 70 as well as to the ultrasonic imaging module 50).
Salehi does not explicitly teach the transducer ring comprises a substrate and the Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) array is based on a micro-electromechanical system (MEMS); and
at least one piezoelectric layer disposed on the substrate;
at least one first electrode connected between the at least one piezoelectric layer and a signal conductor: and
at least one second electrode connected between the at least one piezoelectric layer and a ground conductor;
and that the plurality of transducer array elements are mounted in a linear fashion; and
each of the plurality of transducer array elements is connected to an electronic flex cable that extends through the lumen towards the proximal end of the ICE catheter.
Dausch, however, teaches an Intracardiac echocardiography (ICE) catheter (Paragraph [0096]; three-dimensional intracardiac imaging catheter) comprising:
a body with a longitudinal axis (Fig. 12, length of the catheter) and a distal end (Paragraph [0094]; Fig. 12, portion of catheter with opening 513):
a transducer positioned at the distal end of the ICE catheter (Paragraph [0094]; pmut device 990, Fig. 12), wherein the transducer comprises a substrate (Paragraph [0060]-[0062]; substrate 12, Figs. 4-6) and a micro-electromechanical (MEMS) based Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) array (Paragraphs [0012] and [0027]; MEMS-type medical device is in imaging devices; "microfabricated," "micromachining" and "MEMS" are used interchangeably; Paragraphs [0037]; microfabricated piezoelectric elements; Paragraph [0040]; array of piezoelectric elements… pmut elements in the array) arranged over the substrate (Paragraph [0062]; form the pMUT element shape 22 on substrate 12, Fig. 5), wherein the MEMS based pMUT array is a forward facing assembly (Paragraph [0085]; forward viewing imaging catheter device), and
each transducer array element comprises:
at least one piezoelectric layer disposed on the substrate (Paragraph [0061] and [0062]; piezoelectric material 18; piezoelectric element 22; Figs. 4-6);
at least one first electrode connected between the at least one piezoelectric layer and a signal conductor (Paragraph [0020]; bottom electrode 20; conductive film 66 is deposited in the spaced-apart vias 69, as illustrated in FIG. 5, to provide electrical connection between the bottom electrode 20 and the through-wafer interconnects, Fig. 5 and 6; Paragraph [0089]; An amplifier ASIC may be bonded to the pMUT substrate and connected to the through-wafer interconnects of each pMUT element such that the ultrasonic signal received by each pMUT element); and
at least one second electrode connected between the at least one piezoelectric layer and a ground conductor (Paragraph [0063]; top electrode 32; Paragraph [0049]; the top electrode 32 is a continuous ground electrode across the entire pMUT array).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transducer array of Salehi to have comprised a substrate and be based on a micro-electromechanical system (MEMS) as taught by Dausch because the use of MEMS technology allows medical devices or their components to be manufactured with significant size reduction, especially in particular areas where miniaturized devices are desirable and where MEMS devices are attractive such as intravascular imaging (Dausch, Paragraphs [0004] and [0012]) and further improve the transducer by enhancing the sensitivity of the PMUT elements (Dausch, Paragraph [0026]).
It would further have been obvious to modify each transducer array to comprise at least one piezoelectric layer disposed on the substrate; at least one first electrode connected between the at least one piezoelectric layer and a signal conductor; and at least one second electrode connected between the at least one piezoelectric layer and a ground conductor as taught by Dausch because it would have been a well-understood method of forming the PMUT transducer elements that would have further reduced acoustic leakage and minimize loss of the transducer receive signal and lowers the power required to drive the transducers for transmit (Dausch, Paragraphs [0048] and [0053]).
Together Salehi and Dausch further fails to teach that the plurality of PMUT array elements are mounted in a linear fashion; and
each of the plurality of transducer array elements is connected to an electronic flex cable that extends through the lumen towards the proximal end of the ICE catheter.
Yang, however, teaches an ultrasonic imaging system (Pg. 2, Technical field; an ultrasonic guide
catheter and a puncture system of ultrasonic guidance; Fig. 1) comprising a transducer ring (Pg. 14, Embodiment 6, para. 2; the ultrasonic transducer of all the fan-shaped areas can form a larger transducer array, by ultrasonic phased array technology; Fig. 21) positioned at the distal end of the catheter (Pg. 14, Embodiment 6, para. 2; the carrier 2 is a trumpet-shaped structure set on the distal end of the catheter and can be folded in the sleeve structure 10, please refer to FIG. 19-21, the carrier 2 is a horn-shaped structure, the ultrasonic imaging assembly further comprises a supporting piece for supporting 11; Figs. 19-21);
wherein the plurality of PMUT array elements are mounted in a linear fashion (Fig. 21 shows the elements are arranged in arrays arranged tangentially around the shaft in linear fashion);
each of the plurality of transducer array elements is connected to an electronic flex cable that extends through the lumen towards the proximal end of the ICE catheter (Pg. 12, full para. 2; , the cable 6 is a flexible cable, at the retracted position, the connection part of the cable 6 located
in the carrier 2 and the catheter main body is located between the carrier 2 and the catheter body 1, in the process of the carrier 2 around the hinge 5 to rotate, the part of the flexible cable 6 can be turned a certain angle, ensuring the transducer unit 3 connected with the main machine, as shown in FIG. 3, 4; Pg. 14, Embodiment 6, para. 4; the flexible circuit, transducer is directly arranged on the sheet of the high elasticity, The method can be applied to the instrument with a certain requirement to the space structure. when the sleeve structure 10 moves to the distal end of the catheter body 1, high elastic wire is folded by the sleeve structure 10, the carrier 2 can be folded in the sleeve structure 10; Figs. 4, 20, and 21 show the shaft allows passage of the transducers which are connected to the flexible cable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the plurality of PMUT array elements of Salehi in view of Dausch to have been mounted in a linear fashion as taught by Yang because it would allow arrangement in fan shapes which could be individually excited and received from in different directions and thus enable a phased array configuration (Pg. 14, Para. 2). It further would have been obvious to have modified the catheter such that each of the plurality of transducer array elements is connected to an electronic flex cable that extends through the lumen towards the proximal end of the ICE catheter as further taught by Yang because it further would have allowed the transducers to be foldable into the catheter body and thereby protect the transducers when not in use, and further allow the tissue structures in front of the distal end to be viewed when deployed (Pg. 14, Para. 1-4).
Regarding claim 19, together Salehi, Dausch, and Yang teach all of the limitations of claim 12 as noted above. Dausch further teaches a distal tip of the ICE catheter is coated with a material to provide electrical isolation and transmission of ultrasound signals (Paragraph [0072]; Polymer passivation layer 190 is deposited on the piezoelectric element; provides electrical and chemical insulation from fluid that may come in contact with the device surface during use and may also serves as an acoustic matching layer providing a lower acoustic impedance layer between the transducer face and the fluid; Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified a distal tip of the ICE catheter of Salehi in view of Dausch and Yang to have been coated with a material to provide electrical isolation and transmission of ultrasound signals as taught by Dausch because it would provide electrical and chemical insulation from fluid that may come in contact with the device surface during use and further serve as an acoustic matching layer providing a lower acoustic impedance layer between the transducer face and the fluid (Dausch, Paragraph [0072]).
Regarding claim 25, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Salehi does not explicitly teach each of the plurality of pMUT array elements extends tangentially to the transducer ring, wherein each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows.
Yang, however, further teaches each of the plurality of pMUT array elements extends tangentially to the transducer ring (Fig. 21 shows the elements are arranged in arrays arranged tangentially around the shaft in linear fashion. The columns of two cells are considered to be in a tangential direction), wherein each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows (Fig. 21 shows the elements are arranged as plurality of rows).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the plurality of pMUT array elements of Salehi in view of Dausch and Yang to have extended tangentially to the transducer ring and each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows as further taught by Yang because it would have been a well-known and understood rearrangement of forward facing ultrasound elements that further would allow each element to be individually excited and received from in different directions and thus enable a phased array configuration (Pg. 14, Para. 2).
Regarding claim 26, together Salehi, Dausch, and Yang teach all of the limitations of claim 12 as noted above.
Salehi does not explicitly teach each of the plurality of pMUT array elements extends tangentially to the transducer ring, wherein each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows.
Yang, however, further teaches each of the plurality of pMUT array elements extends tangentially to the transducer ring (Fig. 21 shows the elements are arranged in arrays arranged tangentially around the shaft in linear fashion. The columns of two cells are considered to be in a tangential direction), wherein each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows (Fig. 21 shows the elements are arranged as plurality of rows).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the plurality of pMUT array elements of Salehi in view of Dausch and Yang to have extended tangentially to the transducer ring and each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows as further taught by Yang because it would have been a well-known and understood rearrangement of forward facing ultrasound elements that further would allow each element to be individually excited and received from in different directions and thus enable a phased array configuration (Pg. 14, Para. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the plurality of pMUT array elements of Salehi in view of Dausch and Goldchmit to have extended tangentially to the transducer ring as further taught by Goldchmit because it would have been a well-known and understood rearrangement of forward facing ultrasound elements that further would have helped in aligning the ultrasound field with the visual and/or cutting fields (Paragraphs [0118] and [0120]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Salehi in view of Dausch and Yang as applied to claim 1 above, and further in view of Rehrig (US 20070038111).
Regarding claim 2, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Together Salehi, Dausch, and Yang do not explicitly teach each of the plurality of pMUT array elements having transducer cells of multiple diameters, to achieve a bandwidth greater than 55%.
Rehrig, however, teaches each of the plurality of MEMS based pMUT array elements having transducer cells of multiple diameters (Paragraph [0026]; The array 550 includes a central element 565 and annular aperture elements 560 concentrically positioned around the central element 565, Fig. 5b), to achieve a bandwidth of greater than 55% (Paragraph [0023]; Furthermore, the bandwidth of the imaging transducer, particularly when single crystal PMN-PT is employed as the piezoelectric, can be close to 100%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the transducer of Salehi in view of Dausch and Yang to have comprised cells of multiple diameters to achieve a wide bandwidth as taught by Rehrig because it would improve the transducer's axial resolution, which increases the imaging depth (Rehrig, Paragraph [0023]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Salehi in view of Dausch and Yang as applied to claim 1 above, and further in view of Davis (US 20170209121).
Regarding claim 11, together Salehi, Dausch, and Yang teach all of the limitations of claim 1 as noted above.
Salehi further teaches the ultrasound beams having a bandwidth (Paragraph [0070]; driving frequencies of between 5 MHz and 25 MHz… driving frequencies of between 10 MHz and 20 MHz) including a predetermined fundamental mode vibration of each of a plurality of pMUT array elements (Paragraph [0072]; two or more concentric rings of the ultrasound transducers 70 are provided, each ring or layer of ultrasound transducers 70 may have different characteristics, e.g., different center frequencies, different spacing or different numbers of transducers 70).
Together Salehi, Dausch, and Yang do not explicitly teach that a single array element transmits and receives multiple fundamental mode vibrations simultaneously.
Davis, however, teaches a single array element (Paragraph [0204]; a multi-frequency transmit element, Fig. 9) that transmits and receives multiple fundamental mode vibrations simultaneously (Paragraphs [0204]-[0207]; a multi-frequency transmit element group may be formed by providing micro-elements of varying sizes arranged so as to be controllable as a common element group; connected so as to be activated simultaneously; element sizes in order to produce pings with different multi-frequency combinations; receive elements of the probe are sensitive to all of the transmitted frequencies).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the array elements of Salehi in view of Dausch and Yang such that a single array element transmits and receives multiple fundamental mode vibrations simultaneously as taught by Davis because transmit group may have a unique frequency signature. If different transmitters in a probe have different mixes of micro-element sizes to produce a different frequency signature, then pings transmitted from one transmitter may be distinguished from pings transmitted by a second transmitter, even if pings from the two transmitters are transmitted at the same time or during overlapping ping cycles. Mapping the echoes based on the transmitter frequencies may be tremendously beneficial in increasing ping rates and/or frame rates well beyond the limits imposed by single-frequency imaging (Davis, Paragraphs [0206]-[0207]).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi in view of Dausch and Yang as applied to claim 12 above, and further in view of Hancock (US 20200245977).
Regarding claim 13, together Salehi, Dausch, and Yang teach all of the limitations of claim 12 as noted above.
Dausch further teaches each of the plurality of transducer array elements is a phased array (Paragraph [0091]; multiplexing circuitry can be used to address individual pMUT elements; 2D phased array operation may be achieved by multiplexing the drive signal with appropriate timing).
Together Salehi, Dausch, and Yang do not explicitly teach a linear phased array.
Hancock, however, teaches a phased array can be a linear array (Paragraphs [0049]-[0050]; intravascular ultrasound imaging can be implemented in a phased array; Paragraph [0081]; activates an array of acoustic elements to perform a scan sequence, such as the scan sequence 300 shown in FIG. 5… may describe one-dimensional arrays used to generate two-dimensional images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transducer of array elements of Salehi in view of Dausch and Yang to have been a linear phased array as taught by Hancock because it would have been a well understood configuration of array elements that would have allowed creating 2D images using 1D arrays and further allowed scanning volume without a rotating element, thus allowing the transducer to be placed in contact with the blood vessel with minimal risk of trauma (Hancock, Paragraph [0004]).
Regarding claim 14, together Salehi, Dausch, and Yang teach all of the limitations of claim 12 as noted above.
Dausch further teaches each of the plurality of transducer array elements is a phased array (Paragraph [0091]; multiplexing circuitry can be used to address individual pMUT elements; 2D phased array operation may be achieved by multiplexing the drive signal with appropriate timing).
Together Salehi, Dausch, and Yang do not explicitly teach a circular phased array.
Hancock, however, teaches a phased array can be a circular array (Paragraphs [0049]-[0050]; intravascular ultrasound imaging can be implemented in a phased array; Paragraph [0081]; activates an array of acoustic elements to perform a scan sequence, such as the scan sequence 300 shown in FIG. 5… the array may be an annular array of an IVUS imaging catheter, such as the array 124 shown in FIGS. 6A and 6B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transducer of array elements of Salehi in view of Dausch and Yang to have been a circular phased array as taught by Hancock because it would have been a well understood configuration of array elements that would have allowed creating 2D images using 1D arrays and further allowed scanning volume without a rotating element, thus allowing the transducer to be placed in contact with the blood vessel with minimal risk of trauma (Hancock, Paragraph [0004]).
Regarding claim 15, together Salehi, Dausch, and Yang teach all of the limitations of claim 12 as noted above.
Together Salehi, Dausch, and Yang do not teach the plurality of transducer array elements creates an individual focused beam.
Hancock, however, teaches a plurality of transducer array elements creates an individual focused beam (Paragraph [0082]; scan sequence may be performed by activating apertures of the array to form focused beams of ultrasound energy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transducer array elements of Salehi in view of Dausch and Yang to have created an individual focused beam as taught by Hancock because it would have allowed combining delay-and-sum beamforming to generate a single line of an image which can then be used to generate a 2D image (Paragraph [0082]) and further allowed scanning volume without a rotating element, thus allowing the transducer to be placed in contact with the blood vessel with minimal risk of trauma (Hancock, Paragraph [0004]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi in view of Dausch and Yang as applied to claim 12 above, and further in view of Corl (US 20160029999).
Regarding claim 16, together Salehi, Dausch, and Yang teach all of the limitations of claim 12 as noted above.
Together Salehi, Dausch, and Yang do not teach an electrically isolated shaft to cover a shaft up to an imaging window at the distal end of the body.
Corl, however, teaches a catheter (Paragraph [0009]; intravascular ultrasound (IVUS) device) comprising an electrically isolated shaft to cover a shaft up to an imaging window at the distal end of the body (Paragraph [0063]; control region 708 includes an outer jacket 802 used to insulate the rollable semiconductor substrate 714 and to protect the scanner assembly 700 from the environment; the outer jacket 802 includes… Pebax; Fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the shaft of Salehi in view of Dausch and Yang to comprise an electrically isolated shaft to cover a shaft up to an imaging window at the distal end of the body as taught by Corl because it would protect the scanner assembly from the environment (Corl, Paragraph [0063]).
Regarding claim 17, together Salehi, Dausch, Yang, and Corl teach all of the limitations of claim 16 as noted above.
Corl further teaches the electrically isolated shaft uses a thermoplastic elastomer material with polyamide and polyether backbone blocks to cover the shaft up to the imaging assembly at the distal end of the body (Paragraph [0063]; the outer jacket 802 includes… Pebax; Fig. 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the shaft of Salehi in view of Dausch, Yang, and Corl such that the shaft uses a thermoplastic material with polyamide and polyether backbone blocks as taught by Corl because it may be elected for their biocompatibility, durability, hydrophilic or hydrophobic properties, low-friction properties, ultrasonic permeability, and/or other suitable criteria and further protect the scan assembly from the environment (Corl, Paragraph [0063]).
Claims 20-22, 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Salehi (US 20210128106) in view of Dausch (US 20100168583),Yang (CN-115568919-A, translation of CN-115568919-A relied upon herein), and Rehrig (US 20070038111).
Regarding claim 20, Salehi teaches an intracardiac echocardiographic (ICE) imaging system (Paragraph [0006]; tubular shaft and an ultrasonic transducer array; Paragraph [0046]; medical system 10, Fig. 1) comprising:
an ICE catheter (Paragraphs [0046] and [0051]; introducer sheath 12 and ultrasound transducer 40, Fig. 1) having a longitudinal axis (Paragraph [0056]; longitudinal axis 60, Fig. 2B), a proximal end (Paragraph [0049]; proximal end 34, Fig. 1), and a distal end (Paragraph [0049]; distal end 36, Fig. 1);
a Piezoelectric Micromachined Ultrasonic Transducer (pMUT) array (Paragraph [0074]; ultrasound transducer array 40, Fig. 1; the ultrasound transducers 70 can be piezoelectric micromachined ultrasound transducers (PMUTs)) disposed within the distal end of the ICE catheter (Paragraph [0051]; an ultrasonic transducer array 40 at the distal end 36 of the shaft 32), wherein the pMUT array is a forward facing assembly (Paragraph [0065]; ultrasound transducers 70 in a direction that oblique with respect to the longitudinal axis… providing a substantially forward-directed field-of-view of the ultrasound image, Fig. 2A) and comprises a pMUT array elements (Paragraph [0072]; ultrasound transducers 70 arranged in a circular array about the longitudinal axis 60, Fig. 2A);
a steerable sheath (Paragraph [0063]; sheath 12 includes a steering wire 80 can be manipulated by the user to deflect the distal region of the shaft 32, Fig. 2B) integrated with a built-in forward looking transducer (Paragraph [0065]; ultrasound transducers 70 are disposed within the shaft wall 66… substantially forward-directed) and a transducer ring positioned at a distal end of the ICE catheter (Paragraph [0058]; ultrasonic transducer array 40 is a circular array, Fig. 2A); and
a catheter shaft (Paragraph [0049]; sheath 12 includes a shaft 32) connected at one end to a handle assembly (Paragraph [0049]; a handle mechanism 38 attached to the proximal end 34) and at other end to the MEMS based pMUT array (Paragraph [0051]; an ultrasonic transducer array 40 at the distal end 36 of the shaft 32), and the catheter shaft houses an open-ended lumen (Paragraph [0056]; shaft lumen 39, Fig. 2A; Figs. 1 and 2 show the lumen is open ended.) to allow a passage of a puncture needle (Paragraph [0067]; medical introducer sheath 12… assist in the transseptal puncture procedure; typically by passing a needle through a dilator lumen and across the septum) and an electronic flex cable towards the proximal end of the ICE catheter (Paragraph [0076]; electrical conductors 74; electrical conductors 74 can be strung through the conductor lumens, Fig. 2B), wherein the electronic flex cable is in communication with at least one signal trace (Paragraph [0076]; electrical connection of the ultrasound transducers 70 to the ultrasound imaging module 50 can be accomplished via flexible circuits; Fig. 2B), and is configured to:
direct each of the plurality of pMUT array elements, via the at least one signal trace, to transmit and receive, with respect to heart, ultrasound beams (Paragraph [0055]; introducer sheath 12 is able to transmit and receive ultrasonic signals; Paragraph [0053], [0080]; the ultrasonic images generated from the ultrasound signals… within the heart; Intra-cardiac imaging; Paragraph [0077]; ultrasound transducers 70 to the ultrasound imaging module 50 can be accomplished via flexible circuits);
receive at least one signal from the plurality of pMUT array elements based on transmitting and receiving at least one ultrasound beam of the ultrasound beams (Paragraph [0053]; The imaging signals received back from the ultrasonic transducer array 40); and
construct at least one image of at least a portion of the heart based on the at least one signal (Paragraph [0053]; the ultrasonic images generated from the ultrasound signals… within the heart; Paragraph [0080]; ultrasound imaging module 50 can operate as intra-cardiac imaging system for 3D visualization of the heart chamber).
Salehi does not explicitly teach the transducer comprises a substrate and the Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) array is based on a micro-electromechanical system (MEMS);
that the plurality of PMUT array elements are mounted in a linear fashion;
and the catheter shaft is configured to allow passage of an electronic flex cable;
and pMUT cells of multiple diameters to achieve a bandwidth of greater than 55%.
Dausch, however, teaches an ultrasonic imaging system (Paragraph [0026]; medical ultrasound diagnostic imaging probes) comprising:
an Intracardiac echocardiography (ICE) catheter (Paragraph [0096]; three-dimensional intracardiac imaging catheter) having a longitudinal axis (Fig. 12, length of the catheter), a proximal end (Paragraph [0095]; Fig. 12, portion of catheter near mechanism 505), and a distal end (Paragraph [0094]; Fig. 12, portion of catheter with opening 513);
a transducer positioned at the distal end of the ICE catheter (Paragraph [0094]; pmut device 990, Fig. 12), wherein the transducer comprises a substrate (Paragraph [0060]-[0062]; substrate 12, Figs. 4-6) and a micro-electromechanical (MEMS) based Piezoelectric Micro-Machined Ultrasonic Transducer (pMUT) array (Paragraphs [0012] and [0027]; MEMS-type medical device is in imaging devices; "microfabricated," "micromachining" and "MEMS" are used interchangeably; Paragraphs [0037]; microfabricated piezoelectric elements; Paragraph [0040]; array of piezoelectric elements… pmut elements in the array) arranged over the substrate (Paragraph [0062]; form the pMUT element shape 22 on substrate 12, Fig. 5), wherein the MEMS based pMUT array is a forward facing assembly (Paragraph [0085]; forward viewing imaging catheter device), and
comprises a plurality of pMUT array elements mounted on the substrate (Paragraph [0062]; pmut elements 22 on substrate 12; Patterning of the pMUT device structure 100);
and an electronic flex cable towards the proximal end of the ICE catheter (Paragraph [0085]; catheter device 500 includes associated pMUT 90 integrated with flex cable 507, Fig. 9; Paragraph [0088]; flex cable can be routed through the catheter body and connected through the I/O connector at the back end of the catheter to external control circuitry), the electronic flex cable is in communication with at least one signal trace (Paragraph [0084]; pMUT device 90 may be bonded to a flex cable 507), and is configured to:
direct the MEMS based pMUT array, via the at least one signal trace, to transmit and receive, with respect to heart, ultrasound beams (Paragraph [0042]; bipolar transmit voltage is applied to the pMUT to emit acoustic energy… and returns toward the pMUT).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transducer array of Salehi to have comprised a substrate and be based on a micro-electromechanical system (MEMS) as taught by Dausch because the use of MEMS technology allows medical devices or their components to be manufactured with significant size reduction, especially in particular areas where miniaturized devices are desirable and where MEMS devices are attractive such as intravascular imaging (Dausch, Paragraphs [0004] and [0012]) and further improve the transducer by enhancing the sensitivity of the PMUT elements (Dausch, Paragraph [0026]).
The system of Salehi in view of Dausch further fails to teach that the plurality of PMUT array elements are mounted in a linear fashion;
and the catheter shaft is configured to allow passage of an electronic flex cable;
and the transducer comprises pMUT cells of multiple diameters to achieve a bandwidth of greater than 55%.
Yang, however, teaches an ultrasonic imaging system (Pg. 2, Technical field; an ultrasonic guide
catheter and a puncture system of ultrasonic guidance; Fig. 1) comprising a transducer ring (Pg. 14, Embodiment 6, para. 2; the ultrasonic transducer of all the fan-shaped areas can form a larger transducer array, by ultrasonic phased array technology; Fig. 21) positioned at the distal end of the catheter (Pg. 14, Embodiment 6, para. 2; the carrier 2 is a trumpet-shaped structure set on the distal end of the catheter and can be folded in the sleeve structure 10, please refer to FIG. 19-21, the carrier 2 is a horn-shaped structure, the ultrasonic imaging assembly further comprises a supporting piece for supporting 11; Figs. 19-21);
wherein the plurality of PMUT array elements are mounted in a linear fashion (Fig. 21 shows the elements are arranged in arrays arranged tangentially around the shaft in linear fashion);
and the catheter shaft is configured to allow passage of an electronic flex cable (Pg. 12, full para. 2; , the cable 6 is a flexible cable, at the retracted position, the connection part of the cable 6 located
in the carrier 2 and the catheter main body is located between the carrier 2 and the catheter body 1, in the process of the carrier 2 around the hinge 5 to rotate, the part of the flexible cable 6 can be turned a certain angle, ensuring the transducer unit 3 connected with the main machine, as shown in FIG. 3, 4; Pg. 14, Embodiment 6, para. 4; the flexible circuit, transducer is directly arranged on the sheet of the high elasticity, The method can be applied to the instrument with a certain requirement to the space structure. when the sleeve structure 10 moves to the distal end of the catheter body 1, high elastic wire is folded by the sleeve structure 10, the carrier 2 can be folded in the sleeve structure 10; Figs. 4, 20, and 21 show the shaft allows passage of the transducers which are connected to the flexible cable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the plurality of PMUT array elements of Salehi in view of Dausch to have been mounted in a linear fashion as taught by Yang because it would allow arrangement in fan shapes which could be individually excited and received from in different directions and thus enable a phased array configuration (Pg. 14, Para. 2). It further would have been obvious to have modified the catheter shaft to allow passage of an electronic flex cable as further taught by Yang because it further would have allowed the transducers to be foldable into the catheter body and thereby protect the transducers when not in use, and further allow the tissue structures in front of the distal end to be viewed when deployed (Pg. 14, Para. 1-4).
The system of Salehi in view of Dausch and Yang further fails to teach the transducer comprises pMUT cells of multiple diameters to achieve a bandwidth of greater than 55%.
Rehrig, however, teaches a transducer (Paragraph [0026]; imaging transducer) comprising pMUT (Paragraph [0006]; piezoelectric composite plate using photolithography based micromachining) cells of multiple diameters (Paragraph [0026]; The array 550 includes a central element 565 and annular aperture elements 560 concentrically positioned around the central element 565, Fig. 5b) to achieve a bandwidth of greater than 55% (Paragraph [0023]; Furthermore, the bandwidth of the imaging transducer, particularly when single crystal PMN-PT is employed as the piezoelectric, can be close to 100%).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the transducer of Salehi in view of Dausch and Yang to have comprised cells of multiple diameters to achieve a bandwidth of greater than 55% as taught by Rehrig because it would improve the transducer's axial resolution, which increases the imaging depth (Rehrig, Paragraph [0023]).
Regarding claim 21, together Salehi, Dausch, Yang, and Rehrig teach all of the limitations of claim 20 as noted above.
Rehrig teaches each of the plurality of MEMS based pMUT array elements having transducer cells of multiple diameters (Paragraph [0026]; The array 550 includes a central element 565 and annular aperture elements 560 concentrically positioned around the central element 565, Fig. 5b), to achieve the bandwidth of greater than 55% (Paragraph [0023]; Furthermore, the bandwidth of the imaging transducer, particularly when single crystal PMN-PT is employed as the piezoelectric, can be close to 100%) as noted above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the transducer of Salehi in view of Dausch and Yang to have comprised cells of multiple diameters to achieve a bandwidth of greater than 55% as taught by Rehrig because it would improve the transducer's axial resolution, which increases the imaging depth (Rehrig, Paragraph [0023]).
Regarding claim 22, together Salehi, Dausch, Yang, and Rehrig teach all of the limitations of claim 20 as noted above.
Salehi further teaches the MEMS based pMUT array corresponds to a transducer ring (Paragraph [0057]; transducer array 40; ultrasound transducers 70 arranged in a circular pattern, Fig. 2A) with the plurality of MEMS based pMUT array elements configured to transmit ultrasound beams forward of the distal end of the ICE catheter (Paragraph [0065]; ultrasound transducers 70 in a direction that oblique with respect to the longitudinal axis… providing a substantially forward-directed field-of-view of the ultrasound image, Fig. 2A).
Regarding claim 24, together Salehi, Dausch, Yang, and Rehrig teach all of the limitations of claim 22 as noted above.
Salehi does not explicitly teach the transducer ring corresponds to a linear transducer ring with the MEMS based pMUT array mounted over the substrate in the linear fashion.
Yang, however, further teaches the transducer ring corresponds to a linear transducer ring with the MEMS based pMUT array mounted over the substrate in the linear fashion (Fig. 21 shows the elements are arranged in arrays arranged around the shaft in linear fashion.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the transducer ring of Salehi in view of Dausch, Yang, and Rehrig to have corresponded to a linear transducer ring with the MEMS based pMUT array mounted over the substrate in the linear fashion as taught by Yang because it would have been a well-known and understood rearrangement of forward facing ultrasound elements that further would allow each element to be individually excited and received from in different directions and thus enable a phased array configuration (Pg. 14, Para. 2).
Regarding claim 27, together Salehi, Dausch, Yang, and Rehrig teach all of the limitations of claim 20 as noted above.
Salehi does not explicitly teach each of the plurality of pMUT array elements extends tangentially to the transducer ring.
Salehi does not explicitly teach each of the plurality of pMUT array elements extends tangentially to the transducer ring, wherein each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows.
Yang, however, further teaches each of the plurality of pMUT array elements extends tangentially to the transducer ring (Fig. 21 shows the elements are arranged in arrays arranged tangentially around the shaft in linear fashion. The columns of two cells are considered to be in a tangential direction), wherein each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows (Fig. 21 shows the elements are arranged as plurality of rows).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the plurality of pMUT array elements of Salehi in view of Dausch and Yang and Rehrig to have extended tangentially to the transducer ring and each of the linear phased pMUT arrays comprises a plurality of pMUT cells arranged in a plurality of rows as further taught by Yang because it would have been a well-known and understood rearrangement of forward facing ultrasound elements that further would allow each element to be individually excited and received from in different directions and thus enable a phased array configuration (Pg. 14, Para. 2).
Response to Arguments
Claim Rejections under – 35 U.S.C. §103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
05/16/26
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