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 .
Priority
Application claims 21-35 are provided priority 5/22/2019 based on Parent Application 16419595 (Patent 11607201) of this Continuation application 18964239. Earlier priority of 6/29/2018 is not given since JP2018-124632 does not provide disclosure support of the overlaying limitations of application 18964239 claims 21-35 with regards to repolarization of transmit signals.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-22, 23, 26, 28 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi et. al. (U.S. 20070167814, July 19, 2007)(hereinafter, “Wakabayashi”) in view of Borot et. al. (U.S. 11029400, July 23, 2018, PG-Pub 20200025897 used for below citations.)(hereinafter, “Borot”).
Regarding Claim 21, Wakabayashi teaches: An ultrasound endoscope system (Fig. 1, endoscope ultrasonic system) comprising:
an ultrasound endoscope (Fig. 1, element 5, endoscope, [0091-0092]) including an ultrasound transducer array in which ultrasound transducers are arranged in an array (“The cylindrical outer circumferential face of the ultrasonic transducer and transducer control circuit block 32 is provided with an array-type capacitive ultrasonic transducer 33, and also the inner circumferential side thereof is provided with a transducer control circuit unit 34.” [0101]. See Fig. 2); and
an ultrasound processor apparatus connected to the ultrasound transducers (“…the ultrasonic diagnostic device 4 comprises the capacitive ultrasonic probe device 3 according to the present embodiment, a relay cable portion 21 to be detachably connected to the end of this capacitive ultrasonic probe device 3, an ultrasonic diagnostic equipment 23 to be detachably connected with a connector 22 provided at the end of the relay cable portion 21, and an ultrasonic monitor 24 for displaying an ultrasonic tomogram generated from the ultrasonic echo signal obtained from the capacitive ultrasonic probe device 3 in response to the picture signal to be output from the ultrasonic diagnostic equipment 23 being input. [0096]);
wherein an imaging transmit signal for processing in one or more modes is applied to the ultrasound endoscope via the ultrasound processor apparatus (“…the control circuit 52 controls each of the cyclic selection circuit 43, transmission delay unit 49, transmission waveform generating circuit 50, DC bias voltage generating control circuit 51, filter unit 55, reception delay unit 56, beam synthesis circuit 57, and DC bias voltage generating control circuit 59. Also, the control circuit 52 is connected with a scan setting unit 60 made up of a selection switch and so forth, and a user can select a desired scan mode from radial scanning and sector scanning, and selectively set scan conditions by operating the scan setting unit 60.” [0129]);
and the ultrasound endoscope includes: an illumination window disposed on a more proximal end side than the ultrasound transducer array and emitting illumination light (“A tip portion 13 of the insertion portion 11 is provided with an illumination window 14 emitting illumination light…” [0093]);
an observation window disposed on a more proximal end side than the ultrasound transducer array, through the observation window reflected light of the illumination light entering (“…an observation window 15 to which an objective lens is attached for forming an optical image of a subject such as an affected portion within a body cavity illuminated.” [0093]); and
an imaging element imaging the reflected light entering through the observation window (“The endoscope device 2 comprises an endoscope 5, which is inserted into a body cavity, for optically observing, a light source device 6 for supplying illumination light to an unshown light guide inserted into this endoscope 5, a video processor (or camera control unit) 7 for subjecting an image capturing device built in the endoscope 5 to signal processing, and an endoscope monitor 8 for displaying the endoscope image image-captured by the image capturing device in response to the picture signal to be output from this video processor 7 being input.” [0091]; “…a capacitive ultrasonic transducer unit 38 wherein the m capacitive ultrasonic transducer elements 37 are arrayed in the axial direction of the cylindrical face is formed, thereby providing a configuration facilitating two-dimensional array of the capacitive ultrasonic transducer elements 37 on the cylindrical face.” [0105]. See Figs. 1-2).
With regards to limitation: a repolarization transmit signal for processing in one or more modes is applied to the ultrasound endoscope via the ultrasound processor apparatus one or more of before, after, or interleaved between execution of the imaging transmit signal for processing in one or more modes, Wakabayashi further teaches: “The DC bias voltage control signal is formed within the pulser unit 46 in response to input of a control signal for setting the pulse polarity and pulse width and the like of a DC bias voltage, and is applied to the respective capacitive ultrasonic transducer elements 37 within the capacitive ultrasonic transducer unit 38 which has been turned on.” [0168].
Wakabayashi does not explicitly teach a repolarization transmit signal is applied to the ultrasound endoscope via the ultrasound processor apparatus one or more of before, after, or interleaved between execution of the imaging transmit signal for processing in one or more modes.
Borot in the field of ultrasound imaging systems teaches: In order to maintain the polarization and sensitivity of the ultrasound probe, the transducer elements of the probe may be repolarized, either before, after, or during the transducer operation (e.g., a repolarization sequence could be interleaved between imaging sequences with the probe).” [0021]
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify a repolarization transmit signal in Wakabayashi to be applied to the ultrasound endoscope via the ultrasound processor apparatus one or more of before, after, or interleaved between execution of the imaging transmit signal for processing in one or more modes as taught in Borot to “…maintain the polarization and sensitivity of the ultrasound probe…” (Borot, [0021]).
Regarding Claim 22, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi further teaches: wherein the ultrasound endoscope includes a treatment tool lead-out port disposed on a more proximal end side than the ultrasound transducer array (The tip portion 13 is provided with a channel exit 16, and this channel exit 16 is communicated with a treatment-tool insertion slot 17 near the base of the insertion portion 11 by an unshown internal channel.” [0094]. See Fig. 1).
Regarding Claim 23, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi further teaches: wherein the imaging element is disposed on a more proximal end side than the treatment tool lead-out port (See Figs. 1-2).
Regarding Claim 26, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi does not teach: wherein the ultrasound transducers are each a single crystal transducer.
Borot in the field of ultrasound imaging systems teaches: “The elements 104 of the probe may be made of ferroelectric materials, such as piezoelectric ceramic material such as PZT, PMN-PT, PZN-PT, and PIN-PMN-PT single crystal.” [0020].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ultrasound transducers in the combination of references to each be a single crystal transducer as taught in Rafter for improved potential of sensitivity and bandwidth in the transducer design.
Regarding Claim 28, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi does not teach: wherein a frequency of the repolarization transmit signal is lower than a frequency of the imaging transmit signal.
Borot in the field of ultrasound imaging systems teaches: First plot 200 shows a first repolarization sequence 202 with amplitude 204, pulse width 206, and frequency 208. The first repolarization sequence is unipolar with a positive polarity (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is positive, in this example). Second plot 210 shows a second repolarization sequence 212 with amplitude 214, pulse width 216, and frequency 218. The second repolarization sequence 212 has a larger amplitude 214, smaller pulse width 216, and a lower frequency 218 (with longer time between subsequent pulses) than that of the first repolarization sequence 202. The second repolarization sequence 212 is also unipolar with positive polarity (same direction as polarity of ferroelectric material of the ultrasound transducer elements, in this example). Third plot 220 shows a third repolarization sequence 222 which has a smaller amplitude 224 than the first repolarization sequence 204. Additionally, the third repolarization sequence 222 is unipolar with a negative polarity (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is negative, in this example). Fourth plot 230 shows a fourth repolarization sequence 232 which is bipolar and asymmetric. Specifically, the negative amplitude of the bipolar pulse of the fourth repolarization sequence 232 is greater than the positive amplitude of the bipolar pulse (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is negative, in this example). Thus, the mean amplitude of the fourth repolarization sequence 232 is negative and non-zero. In alternate embodiments, the repolarization sequence may be bipolar, similar to repolarization sequence 232, but symmetric (e.g., symmetric across the x-axis so that the mean amplitude of the pulse is zero).” [0023]; “Though the graphs in FIG. 3 all show repolarization sequences with a same, unipolar, positive polarity repolarization transmit pulse, different repolarization sequence transmit pulses may be used in place of those shown in FIG. 3 (such as any of the transmit pulses of the repolarization sequences shown in FIG. 2, or another repolarization transmit pulse sequence with different combinations of amplitude, frequency, PRF, polarity, and pulse width). Each graph of FIG. 3 shows time on the x-axis and voltage (positive and negative) on the y-axis.” [0024].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that a frequency of the repolarization transmit signal is lower than a frequency of the imaging transmit signal as taught in Borot to “…maintain the polarization and sensitivity of the ultrasound probe…” (Borot, [0021]).
Regarding Claim 30, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi does not teach: wherein the repolarization transmit signal is applied to the ultrasound endoscope when the ultrasound endoscope is not inserted in a body cavity of a subject.
Borot in the field of ultrasound imaging systems teaches: “Specifically, as explained further below with reference to FIGS. 2-5, in order to image an object (such as tissue of a patient), one or more imaging sequences of transmit pulses may be applied to elements of an ultrasound transducer. These transmit signals of the imaging sequences may be adapted for imaging (e.g., for sending sound waves into the object to be imaged and receiving echo signals used to generate an image of the object). In order to reduce depolarization of the probe and maintain a sensitivity of the probe, a repolarization sequence of transmit pulses, different from the transmit pulses of the imaging sequences, may be applied to the ultrasound transducer…The repolarization sequence is separate from the imaging sequence and may be applied before, after, or interleaved between imaging sequences, as explained further below with reference to FIG. 3. This arrangement of the repolarization sequence(s) may allow the sensitivity of the ultrasound transducer to stay at an upper threshold level over time, thereby resulting in a more stable ultrasound probe and increasing imaging quality.” [0021].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the repolarization transmit signal in the combination of references is applied to the ultrasound endoscope when the ultrasound endoscope is not inserted in a body cavity of a subject as taught in Borot “…resulting in a more stable ultrasound probe and increasing imaging quality.” (Borot, [0021]).
Regarding Claim 31, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi further teaches: further comprising: an endoscope processor apparatus that generates an endoscope image from an image signal acquired by the imaging element, wherein the ultrasound endoscope is connected to the endoscope processor apparatus (“The endoscope device 2 comprises an endoscope 5, which is inserted into a body cavity, for optically observing, a light source device 6 for supplying illumination light to an unshown light guide inserted into this endoscope 5, a video processor (or camera control unit) 7 for subjecting an image capturing device built in the endoscope 5 to signal processing, and an endoscope monitor 8 for displaying the endoscope image image-captured by the image capturing device in response to the picture signal to be output from this video processor 7 being input.” [0091]; “…the ultrasonic diagnostic device 4 comprises the capacitive ultrasonic probe device 3 according to the present embodiment, a relay cable portion 21 to be detachably connected to the end of this capacitive ultrasonic probe device 3, an ultrasonic diagnostic equipment 23 to be detachably connected with a connector 22 provided at the end of the relay cable portion 21, and an ultrasonic monitor 24 for displaying an ultrasonic tomogram generated from the ultrasonic echo signal obtained from the capacitive ultrasonic probe device 3 in response to the picture signal to be output from the ultrasonic diagnostic equipment 23 being input. [0096]; “…a capacitive ultrasonic transducer unit 38 wherein the m capacitive ultrasonic transducer elements 37 are arrayed in the axial direction of the cylindrical face is formed, thereby providing a configuration facilitating two-dimensional array of the capacitive treatment ultrasonic transducer elements 37 on the cylindrical face.” [0105]).
Claims 24-25,27,33-34 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi in view of Borot as applied to claim 21 above, and further in view of Courtney et. al. (U.S. 20160045184, February 18, 2016)(hereinafter, “Courtney”).
Regarding Claim 24, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
With regards to limitation: wherein a thickness of a piezoelectric element forming the ultrasound transducers is 75 pm to 125 pm, Wakabayashi further teaches a piezoelectric transducer, Wakabayashi claim 25.
Wakabayashi does not teach the thickness of the piezoelectric element is 75 pm to 125 pm.
Courtney in the field of ultrasound image-guided systems teaches: “ The ultrasonic impedance of the first matching layer 415 was increased to about 8 Mrayls from the value of about 5.9 Mrayl used in the baseline imaging transducer stack and was necessary to help maintain a similar ultrasonic excitation response as said baseline imaging transducer stack. The increased acoustic impedance can be achieved, for example by adding some tungsten powder to the silver epoxy (or alternatively, the top metal electrode can be made thicker (0.6-1.5 um in thickness) and a tungsten loaded or alumina loaded non-conductive epoxy mixture can be used). On the bottom face of the transducer, a conductive epoxy layer is used as a backing layer 425. The backing layer 425 is of finite thickness such that the total thickness of the transducer fits inside the catheter.” [0246].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that the piezoelectric element is 75 pm to 125 pm as taught in Courtney for suitable “…2D and 3D ultrasound imaging in a primary catheter device…” (Courtney, [0244]) and “… the total thickness of the transducer fits inside the catheter…” (Courtney, [0244]).
Regarding Claim 25, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
With regards to limitation: wherein the thickness of the piezoelectric element forming the ultrasound transducers is 90 pm to 125 pm, Wakabayashi further teaches a piezoelectric transducer, Wakabayashi claim 25.
Wakabayashi does not teach the thickness of the piezoelectric element is 90 pm to 125 pm.
Courtney in the field of ultrasound image-guided systems teaches: “ The ultrasonic impedance of the first matching layer 415 was increased to about 8 Mrayls from the value of about 5.9 Mrayl used in the baseline imaging transducer stack and was necessary to help maintain a similar ultrasonic excitation response as said baseline imaging transducer stack. The increased acoustic impedance can be achieved, for example by adding some tungsten powder to the silver epoxy (or alternatively, the top metal electrode can be made thicker (0.6-1.5 um in thickness) and a tungsten loaded or alumina loaded non-conductive epoxy mixture can be used). On the bottom face of the transducer, a conductive epoxy layer is used as a backing layer 425. The backing layer 425 is of finite thickness such that the total thickness of the transducer fits inside the catheter.” [0246].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that the piezoelectric element is 90 pm to 125 pm as taught in Courtney for suitable “…2D and 3D ultrasound imaging in a primary catheter device…” (Courtney, [0244]) and “… the total thickness of the transducer fits inside the catheter…” (Courtney, [0244]).
Regarding Claim 27, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
The combination of references does not teach: wherein a frequency of the imaging transmit signal is in a frequency band of 7 MHz to 8 MHz.
Courtney in the field of ultrasound image-guided systems teaches: “FIG. 16 shows a baseline imaging transducer stack 300 that is suitable for 2D and 3D ultrasound imaging in a primary catheter device that can be fabricated to have an imaging operational frequency in the range of 0.5-100 MHz or more commonly in the range of 4-60 MHz.” [0244].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that a frequency of the imaging transmit signal is in a frequency band of 7 MHz to 8 MHz as taught in Courtney for suitable “…2D and 3D ultrasound imaging in a primary catheter device…” (Courtney, [0244]).
Regarding Claim 33, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi further teaches: further comprising: an endoscope processor apparatus that generates an endoscope image from an image signal acquired by the imaging element, wherein the ultrasound endoscope is connected to the endoscope processor apparatus (“The endoscope device 2 comprises an endoscope 5, which is inserted into a body cavity, for optically observing, a light source device 6 for supplying illumination light to an unshown light guide inserted into this endoscope 5, a video processor (or camera control unit) 7 for subjecting an image capturing device built in the endoscope 5 to signal processing, and an endoscope monitor 8 for displaying the endoscope image image-captured by the image capturing device in response to the picture signal to be output from this video processor 7 being input.” [0091]; “…the ultrasonic diagnostic device 4 comprises the capacitive ultrasonic probe device 3 according to the present embodiment, a relay cable portion 21 to be detachably connected to the end of this capacitive ultrasonic probe device 3, an ultrasonic diagnostic equipment 23 to be detachably connected with a connector 22 provided at the end of the relay cable portion 21, and an ultrasonic monitor 24 for displaying an ultrasonic tomogram generated from the ultrasonic echo signal obtained from the capacitive ultrasonic probe device 3 in response to the picture signal to be output from the ultrasonic diagnostic equipment 23 being input. [0096]; “…a capacitive ultrasonic transducer unit 38 wherein the m capacitive ultrasonic transducer elements 37 are arrayed in the axial direction of the cylindrical face is formed, thereby providing a configuration facilitating two-dimensional array of the capacitive treatment ultrasonic transducer elements 37 on the cylindrical face.” [0105]).
Wakabayashi does not teach: a thickness of a piezoelectric element forming the ultrasound transducers is 75 pm to 125 pm, a frequency of the imaging transmit signal is a frequency band of 7 MHz to 8 MHz level, and a frequency of the repolarization transmit signal is lower than the frequency of the imaging transmit signal.
Borot in the field of ultrasound imaging systems teaches: First plot 200 shows a first repolarization sequence 202 with amplitude 204, pulse width 206, and frequency 208. The first repolarization sequence is unipolar with a positive polarity (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is positive, in this example). Second plot 210 shows a second repolarization sequence 212 with amplitude 214, pulse width 216, and frequency 218. The second repolarization sequence 212 has a larger amplitude 214, smaller pulse width 216, and a lower frequency 218 (with longer time between subsequent pulses) than that of the first repolarization sequence 202. The second repolarization sequence 212 is also unipolar with positive polarity (same direction as polarity of ferroelectric material of the ultrasound transducer elements, in this example). Third plot 220 shows a third repolarization sequence 222 which has a smaller amplitude 224 than the first repolarization sequence 204. Additionally, the third repolarization sequence 222 is unipolar with a negative polarity (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is negative, in this example). Fourth plot 230 shows a fourth repolarization sequence 232 which is bipolar and asymmetric. Specifically, the negative amplitude of the bipolar pulse of the fourth repolarization sequence 232 is greater than the positive amplitude of the bipolar pulse (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is negative, in this example). Thus, the mean amplitude of the fourth repolarization sequence 232 is negative and non-zero. In alternate embodiments, the repolarization sequence may be bipolar, similar to repolarization sequence 232, but symmetric (e.g., symmetric across the x-axis so that the mean amplitude of the pulse is zero).” [0023]; “Though the graphs in FIG. 3 all show repolarization sequences with a same, unipolar, positive polarity repolarization transmit pulse, different repolarization sequence transmit pulses may be used in place of those shown in FIG. 3 (such as any of the transmit pulses of the repolarization sequences shown in FIG. 2, or another repolarization transmit pulse sequence with different combinations of amplitude, frequency, PRF, polarity, and pulse width). Each graph of FIG. 3 shows time on the x-axis and voltage (positive and negative) on the y-axis.” [0024].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that a frequency of the repolarization transmit signal is lower than a frequency of the imaging transmit signal as taught in Borot to “…maintain the polarization and sensitivity of the ultrasound probe…” (Borot, [0021]).
The combination of references does not teach: a thickness of a piezoelectric element forming the ultrasound transducers is 75 pm to 125 pm and a frequency of the imaging transmit signal is a frequency band of 7 MHz to 8 MHz level
Courtney in the field of ultrasound image-guided systems teaches: “FIG. 16 shows a baseline imaging transducer stack 300 that is suitable for 2D and 3D ultrasound imaging in a primary catheter device that can be fabricated to have an imaging operational frequency in the range of 0.5-100 MHz or more commonly in the range of 4-60 MHz.” [0244]; “ The ultrasonic impedance of the first matching layer 415 was increased to about 8 Mrayls from the value of about 5.9 Mrayl used in the baseline imaging transducer stack and was necessary to help maintain a similar ultrasonic excitation response as said baseline imaging transducer stack. The increased acoustic impedance can be achieved, for example by adding some tungsten powder to the silver epoxy (or alternatively, the top metal electrode can be made thicker (0.6-1.5 um in thickness) and a tungsten loaded or alumina loaded non-conductive epoxy mixture can be used). On the bottom face of the transducer, a conductive epoxy layer is used as a backing layer 425. The backing layer 425 is of finite thickness such that the total thickness of the transducer fits inside the catheter.” [0246].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that the piezoelectric element is 75 pm to 125 pm and a frequency of the imaging transmit signal is a frequency band of 7 MHz to 8 MHz level as taught in Courtney for suitable “…2D and 3D ultrasound imaging in a primary catheter device…” (Courtney, [0244]) and “… the total thickness of the transducer fits inside the catheter…” (Courtney, [0244]).
Regarding Claim 34, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi further teaches: an endoscope processor apparatus that generates an endoscope image from an image signal acquired by the imaging element, wherein the ultrasound endoscope is connected to the endoscope processor apparatus (“The endoscope device 2 comprises an endoscope 5, which is inserted into a body cavity, for optically observing, a light source device 6 for supplying illumination light to an unshown light guide inserted into this endoscope 5, a video processor (or camera control unit) 7 for subjecting an image capturing device built in the endoscope 5 to signal processing, and an endoscope monitor 8 for displaying the endoscope image image-captured by the image capturing device in response to the picture signal to be output from this video processor 7 being input.” [0091]; “…the ultrasonic diagnostic device 4 comprises the capacitive ultrasonic probe device 3 according to the present embodiment, a relay cable portion 21 to be detachably connected to the end of this capacitive ultrasonic probe device 3, an ultrasonic diagnostic equipment 23 to be detachably connected with a connector 22 provided at the end of the relay cable portion 21, and an ultrasonic monitor 24 for displaying an ultrasonic tomogram generated from the ultrasonic echo signal obtained from the capacitive ultrasonic probe device 3 in response to the picture signal to be output from the ultrasonic diagnostic equipment 23 being input. [0096]; “…a capacitive ultrasonic transducer unit 38 wherein the m capacitive ultrasonic transducer elements 37 are arrayed in the axial direction of the cylindrical face is formed, thereby providing a configuration facilitating two-dimensional array of the capacitive treatment ultrasonic transducer elements 37 on the cylindrical face.” [0105]).
Wakabayashi does not teach: a thickness of a piezoelectric element forming the ultrasound transducers is 75 pm to 125 pm, and a frequency of the repolarization transmit signal is lower than a frequency of the imaging transmit signal.
Borot in the field of ultrasound imaging systems teaches: First plot 200 shows a first repolarization sequence 202 with amplitude 204, pulse width 206, and frequency 208. The first repolarization sequence is unipolar with a positive polarity (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is positive, in this example). Second plot 210 shows a second repolarization sequence 212 with amplitude 214, pulse width 216, and frequency 218. The second repolarization sequence 212 has a larger amplitude 214, smaller pulse width 216, and a lower frequency 218 (with longer time between subsequent pulses) than that of the first repolarization sequence 202. The second repolarization sequence 212 is also unipolar with positive polarity (same direction as polarity of ferroelectric material of the ultrasound transducer elements, in this example). Third plot 220 shows a third repolarization sequence 222 which has a smaller amplitude 224 than the first repolarization sequence 204. Additionally, the third repolarization sequence 222 is unipolar with a negative polarity (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is negative, in this example). Fourth plot 230 shows a fourth repolarization sequence 232 which is bipolar and asymmetric. Specifically, the negative amplitude of the bipolar pulse of the fourth repolarization sequence 232 is greater than the positive amplitude of the bipolar pulse (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is negative, in this example). Thus, the mean amplitude of the fourth repolarization sequence 232 is negative and non-zero. In alternate embodiments, the repolarization sequence may be bipolar, similar to repolarization sequence 232, but symmetric (e.g., symmetric across the x-axis so that the mean amplitude of the pulse is zero).” [0023]; “Though the graphs in FIG. 3 all show repolarization sequences with a same, unipolar, positive polarity repolarization transmit pulse, different repolarization sequence transmit pulses may be used in place of those shown in FIG. 3 (such as any of the transmit pulses of the repolarization sequences shown in FIG. 2, or another repolarization transmit pulse sequence with different combinations of amplitude, frequency, PRF, polarity, and pulse width). Each graph of FIG. 3 shows time on the x-axis and voltage (positive and negative) on the y-axis.” [0024].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that a frequency of the repolarization transmit signal is lower than a frequency of the imaging transmit signal as taught in Borot to “…maintain the polarization and sensitivity of the ultrasound probe…” (Borot, [0021]).
The combination of references does not teach: a thickness of a piezoelectric element forming the ultrasound transducers is 75 pm to 125 pm.
Courtney in the field of ultrasound image-guided systems teaches: “ The ultrasonic impedance of the first matching layer 415 was increased to about 8 Mrayls from the value of about 5.9 Mrayl used in the baseline imaging transducer stack and was necessary to help maintain a similar ultrasonic excitation response as said baseline imaging transducer stack. The increased acoustic impedance can be achieved, for example by adding some tungsten powder to the silver epoxy (or alternatively, the top metal electrode can be made thicker (0.6-1.5 um in thickness) and a tungsten loaded or alumina loaded non-conductive epoxy mixture can be used). On the bottom face of the transducer, a conductive epoxy layer is used as a backing layer 425. The backing layer 425 is of finite thickness such that the total thickness of the transducer fits inside the catheter.” [0246].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that the piezoelectric element is 75 pm to 125 pm as taught in Courtney for suitable “…2D and 3D ultrasound imaging in a primary catheter device…” (Courtney, [0244]) and “… the total thickness of the transducer fits inside the catheter…” (Courtney, [0244]).
Regarding Claim 36, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
Wakabayashi further teaches: wherein the ultrasound endoscope includes a treatment tool lead-out port disposed on a more proximal end side than the ultrasound transducer array (The tip portion 13 is provided with a channel exit 16, and this channel exit 16 is communicated with a treatment-tool insertion slot 17 near the base of the insertion portion 11 by an unshown internal channel.” [0094]. See Fig. 1), the imaging element is disposed on a more proximal end side than the treatment tool lead-out port (See Figs. 1-2).
Wakabayashi does not teach: a thickness of a piezoelectric element forming the ultrasound transducers is 75 pm to 125 pm, and a frequency of the repolarization transmit signal is lower than a frequency of the imaging transmit signal.
Borot in the field of ultrasound imaging systems teaches: First plot 200 shows a first repolarization sequence 202 with amplitude 204, pulse width 206, and frequency 208. The first repolarization sequence is unipolar with a positive polarity (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is positive, in this example). Second plot 210 shows a second repolarization sequence 212 with amplitude 214, pulse width 216, and frequency 218. The second repolarization sequence 212 has a larger amplitude 214, smaller pulse width 216, and a lower frequency 218 (with longer time between subsequent pulses) than that of the first repolarization sequence 202. The second repolarization sequence 212 is also unipolar with positive polarity (same direction as polarity of ferroelectric material of the ultrasound transducer elements, in this example). Third plot 220 shows a third repolarization sequence 222 which has a smaller amplitude 224 than the first repolarization sequence 204. Additionally, the third repolarization sequence 222 is unipolar with a negative polarity (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is negative, in this example). Fourth plot 230 shows a fourth repolarization sequence 232 which is bipolar and asymmetric. Specifically, the negative amplitude of the bipolar pulse of the fourth repolarization sequence 232 is greater than the positive amplitude of the bipolar pulse (since the direction of polarity of the ferroelectric material of the ultrasound transducer elements is negative, in this example). Thus, the mean amplitude of the fourth repolarization sequence 232 is negative and non-zero. In alternate embodiments, the repolarization sequence may be bipolar, similar to repolarization sequence 232, but symmetric (e.g., symmetric across the x-axis so that the mean amplitude of the pulse is zero).” [0023]; “Though the graphs in FIG. 3 all show repolarization sequences with a same, unipolar, positive polarity repolarization transmit pulse, different repolarization sequence transmit pulses may be used in place of those shown in FIG. 3 (such as any of the transmit pulses of the repolarization sequences shown in FIG. 2, or another repolarization transmit pulse sequence with different combinations of amplitude, frequency, PRF, polarity, and pulse width). Each graph of FIG. 3 shows time on the x-axis and voltage (positive and negative) on the y-axis.” [0024].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that a frequency of the repolarization transmit signal is lower than a frequency of the imaging transmit signal as taught in Borot to “…maintain the polarization and sensitivity of the ultrasound probe…” (Borot, [0021]).
The combination of references does not teach: a thickness of a piezoelectric element forming the ultrasound transducers is 75 pm to 125 pm.
Courtney in the field of ultrasound image-guided systems teaches: “ The ultrasonic impedance of the first matching layer 415 was increased to about 8 Mrayls from the value of about 5.9 Mrayl used in the baseline imaging transducer stack and was necessary to help maintain a similar ultrasonic excitation response as said baseline imaging transducer stack. The increased acoustic impedance can be achieved, for example by adding some tungsten powder to the silver epoxy (or alternatively, the top metal electrode can be made thicker (0.6-1.5 um in thickness) and a tungsten loaded or alumina loaded non-conductive epoxy mixture can be used). On the bottom face of the transducer, a conductive epoxy layer is used as a backing layer 425. The backing layer 425 is of finite thickness such that the total thickness of the transducer fits inside the catheter.” [0246].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that the piezoelectric element is 75 pm to 125 pm as taught in Courtney for suitable “…2D and 3D ultrasound imaging in a primary catheter device…” (Courtney, [0244]) and “… the total thickness of the transducer fits inside the catheter…” (Courtney, [0244]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Wakabayashi in view of Borot as applied to claim 21 above, and further in view of Onishi (U.S. 20060049715, March 9, 2006)(hereinafter, “Onishi).
Regarding Claim 29, the combination of Wakabayashi and Borot teach the claim limitations as noted above.
The combination of references does not teach: wherein a voltage of the repolarization transmit signal is an alternate current voltage, and a waveform of the repolarization transmit signal is a pulse waveform.
Onishi in the field of transducer-based systems teaches: “An AC driving voltage supplied from the AC voltage source A has a sine wave shape, as shown in FIG. 13, in which an absolute value of a maximum voltage at a positive side is the same as that of a minimum voltage at a negative side.” [0005]; “An AC driving voltage supplied from the AC voltage source A connected to the stacked piezoelectric element D1 also has a waveform shown in FIG. 13.” [0008]; “…by connecting each AC voltage source to each electromechanical transducer and applying AC driving voltages having opposite polarities to the electromechanical transducers, the absolute value of the maximum forward voltage applied in the polarization direction of the electro-mechanical transducer can be made to be larger than the absolute value of the maximum reverse voltage applied in the direction opposite to the polarization direction.” [0038]
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references such that a voltage of the repolarization transmit signal is an alternate current voltage, and a waveform of the repolarization transmit signal is a pulse waveform as taught in Onishi such that “…the absolute value of the maximum forward voltage applied in the polarization direction of the electro-mechanical transducer can be made to be larger than the absolute value of the maximum reverse voltage applied in the direction opposite to the polarization direction.” (Onishi, [0038]).
Allowable Subject Matter
Claims 32 and 35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Makita U.S. 20040260181 teaches an ultrasound repolarization system
Aoki U.S. 20130231568 teaches an ultrasound polarization system where the amplitude depends on the difference between acoustic impedances of discontinuous surfaces of a received reflection wave signal.
Ronnekleiv JP 2017516093 connected to U.S. 20180188077 teaches a sensor system where complex amplitudes represent the transmission path from polarization interleaver to polarize a sensor array.
Nishiwaki U.S. 20140066778 teaches an ultrasound system with multiplexer that has a group of ports on the element unit to control the interconnection between the ports on the cable and the ports on the element unit sides.
The combinations of exemplary prior art do not provide teachings/suggestions nor an apparent rational or desirability to modify individually or in combination to render obvious the recited claim limitations of claims 32 or 35.
Conclusion
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/AMAL ALY FARAG/Primary Examiner, Art Unit 3798