DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments filed 07/30/2025 have been entered. Currently claims 1, 4, 5, 8, 9, 11, 15-17, 21-23, 28, 39, 40, 43, 48-50, 52, 56 and 81 are pending with claims 48-50, 52,56 and 81 being withdrawn.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow et al., (US5456259A) in view of Hutchins et al., (US 20140142432 A1) as further evidenced by Ozawa et al., (US 20170365771 A1).
Regarding claim 1, Barlow teaches:
An ultrasound transducer assembly comprising (Abstract a catheter with an ultrasonic array):
a piezoelectric layer configured to resonate and generate ultrasound signals along an axis (fig. 2 the transducer elements 19 are arranged around the axis A col. 5 lines 24-27) around a predetermined ultrasound frequency (col. 8 line 51-55 the desired frequency is 20MHz) between 10 and 50 MHz (col. 8 line 51-55 the desired frequency is 20MHz);
a conductive backing layer connected to the piezoelectric layer, wherein the conductive backing layer is configured to operate as a conductive electrode of the ultrasound assembly (fig. 10 acoustic backing layer 101 is electrically conducting so that there is an electrical path from the transducer annulus 100 that contains the piezoelectric transducer elements through the layer 101 to the collar 102 col. 9 lines 40-48 ); and
a rigid body over which the conductive backing layer is positioned (fig. 10 collar 102, and conductive backing layer 101 is provided over the collar 102), the rigid body assembled for encompassing a central longitudinal axis of a catheter body (fig. 10 collar 102 has a central axis lumen)
wherein a rigidity of the rigid body is configured to attenuate ultrasound signals directed toward the central longitudinal axis of the catheter body and to direct ultrasound signals away from the central longitudinal axis of the catheter body (fig. 10 tungsten carbide tubular support 102, which is a highly reflective material capable of direct ultrasound signals away from the central longitudinal axis of the catheter (as evidenced by Ozawa).
However the combination of references is still silent regarding wherein the piezoelectric layer has a width to thickness ratio between 2 and 7 and wherein the thickness of the piezoelectric layer is measured along the axis.
In the same ultrasound field of endeavor, Hutchins teaches wherein the piezoelectric layer has a width to thickness ratio between 2 and 7 (fig. 3a the height of the piezoelectric stack of ultrasound transducer 55 is 80 microns and the width is 300 microns, which is width to thickness ratio of 3.75 [0074]) and wherein the thickness of the piezoelectric layer is measured along the axis (see annotated fig. 3a the thickness t is measured along the axis).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the width to thickness ratio of the piezoelectric assembly of modified Barlow with the width to thickness ratio of the piezoelectric structure of Hutchins, as both inventions relate to ultrasound devices and would yield the predictable result of an ultrasound device having a width to thickness ratio of 3.75 wherein the thickness of the piezoelectric layer is measured along the axis to one of ordinary skill in the art. One of ordinary skill would be able to make sure a substitution, and the results of the modified Jacobs having a piezoelectric structure with a width to thickness ratio of 3.75 are reasonable predictable.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 1 above, and further in view of Kurokawa et al., (“Estimation of size of red blood cell aggregates using backscattering property of high-frequency ultrasound: In vivo evaluation”, Japanese Journal of Applied Physics 55, 07KF12 (2016)), (hereinafter “Kurokawa”) and Wodnicki et al., (Co-Integrated PIN-PMN-PT 2-D Array and Transceiver Electronics by Direct Assembly Using a 3-D Printed Interposer Grid Frame. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Feb, hereinafter “Wodnicki”).
Regarding claim 4, modified Barlow teaches the assembly of claim 1, but fails to explicitly disclose a wavelength of a resonant frequency of an external environment outside of blood
In the same ultrasound field of endeavor, Kurokawa teaches a wavelength of a resonant frequency of an external environment of blood (Materials and Methods: the ultrasonic wavelength in blood is 40 µm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the external environment of Kurokawa, as this would improve the SNR by coherent integration and modification of the measurement conditions (see Kurokawa Introduction).
However the combination of references still fails to explicitly disclose the width of the piezoelectric layer is at least a wavelength of a resonant frequency of an external environment of blood.
In the same ultrasound field of endeavor, Wodnicki teaches the width of the piezoelectric layer is at least a wavelength of a resonant frequency of an external environment outside of blood (Table 3: As established in Kurokawa, the wavelength in blood is 40µm, and the piezoelectric layer is 280µm thick, which is at least 40µm pg. 391 ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the assembly of Wodnicki, as this would improve yield during the fabrication of the arrays and lower cost(pg. 388).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 1 above, and further in view of Cabrera-Munoz et al., ("Forward-looking 30-MHz phased-array transducer for peripheral intravascular imaging," Sensors and Actuators A: Physical, Volume 280, 2018, Pages 145-163, hereinafter “Munoz”).
Regarding claim 5 modified Barlow teaches the assembly of claim 1, but fails to explicitly disclose wherein the thickness of the piezoelectric layer is equal to or less than about one half a wavelength of a resonant frequency of the piezoelectric layer material.
However in the ultrasound field of endeavor, Munoz teaches wherein the thickness of the piezoelectric layer is equal to or less than about one half a wavelength of a resonant frequency of the piezoelectric layer material (Table 2 the piezoelectric material has a speed of sound c of 4600m/s and Table 3 parallel resonant frequency of 40.8 MHz (see pg. 156 fa is parallel resonant frequencies); this results in a wavelength of 112.745µm; since the thickness of the piezoelectric material (table 1 pg. 147) is 27 µm, it is less than half of the wavelength of a resonant frequency of the piezoelectric layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the ratio of Munoz, as this would minimize the risk of having unconnected elements (see Munoz pg. 147).
Regarding claim 15, modified Barlow teaches the assembly of claim 1, but fails to explicitly disclose a metallic conductive layer over a top side of the piezoelectric layer, the metallic conductive layer configured to operate as a signal or ground layer.
However, in the same ultrasound field of endeavor, Munoz teaches a metallic conductive layer over a top side of the piezoelectric layer (fig. 4B the piezoelectric elements where sputtered with a metallic layer (pg. 149) and ends with the 1st matching layer laid upon it resulting in a 202 composite and 1st matching layer) the metallic conductive layer configured to operate as a signal or ground layer (fig. 4 active and ground electrodes were sputtered on the bottom and top sides of the composites pg. 149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the fabrication method of Munoz, as this would result in a more reliable fabrication method (see Munoz pg. 148).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 1 above, and further in view of Mamiya (US20170079628A1) as further evidenced by Sheng et al., (US20200254230A1).
Regarding claim 8, modified Barlow teaches the assembly of claim 1, but fails to explicitly disclose wherein the rigid body is comprised substantially of a material having a Shore hardness of at least about 65D.
However in the same ultrasound field of endeavor, Mamiya teaches wherein the rigid body is comprised substantially of a material having a Shore hardness of at least about 65D (fig. 6, the distal innertube may be made of polyether ether ketone[0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the Shore hardness material of Mamiya, as then the flexibility of the outer sheath would then not be easily reduced (see Mamiya [0097]). Sheng teaches that a PEEK has a shore D hardness of 50-95 D (see Sheng [0043]), and therefore the combination of references reads upon the limitation of the rigid body comprised substantially of a material having a shore hardness of at least about 65D.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 1 above, and further in view of Wodnicki.
Regarding claim 9, modified Barlow teaches the assembly of claim 1, but fails to explicitly disclose wherein the conductive backing layer is configured to provide about -20dB or a more negative value of round-trip attenuation.
However in the same ultrasound field of endeavor, Wodnicki teaches wherein the conductive backing layer is configured to provide about -20dB or a more negative value of round-trip attenuation (pg. 392 the backing thickness, made of E-Solder 3022 is chosen so that the roundtrip attenuation would be greater than -40 dB).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the assembly of Wodnicki, as this would improve yield during the fabrication of the arrays and lower cost(pg. 388).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 1 above, and further in view of Osawa (US20080238259A1) and Zhao et al., (US20180360423A1).
Regarding claim 11, modified Barlow teaches the assembly of claim 1, but fails to explicitly disclose a thickness of the piezoelectric layer.
In the same ultrasound field of endeavor, Osawa teaches the thickness of the piezoelectric layer (fig. 2 there are three layers of piezoelectric ceramic, and each has a thickness of 100 μm, therefore the thickness is 300 μm [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify Barlow with the backing layer of Osawa, as this would quickly attenuate any unnecessary generated ultrasonic waves while suppressing lateral vibration of the transducers (see Osawa [0036]).
However the combination of references still does not teach wherein the conductive backing layer has a thickness of about a tenth to about a half of the thickness of the piezoelectric layer.
In the same ultrasound field of endeavor, Zhao teaches wherein the conductive backing layer has a thickness of about a tenth to about a half of the thickness of the piezoelectric layer ([0007] the backing material is an epoxy with metal; [0009] the backing material may be 50 μm, which is between a tenth and about a half of the thickness of the piezoelectric layer, which, as established by Osawa, is 300 μm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the backing material dimensions of Zhao, as this would provide structure and rigidity (see Zhao [0038]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 15 above, and further in view of Toda (US20160332198A1).
Regarding claim 16, modified Barlow teaches the assembly of claim 15, but fails to explicitly disclose wherein the metallic conductive layer is comprised substantially of a conductive epoxy onto which a malleable metal is applied, and wherein the malleable metal has a thickness of at least about 0.5 microns.
However in the same ultrasound field of endeavor, Munoz teaches wherein the metallic conductive layer is comprised substantially of a conductive epoxy (fig. 4 the 1st matching layer is a silver epoxy and makes up a part of the metallic conductive layer pg. 147).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the metallic layer of Munoz, as this would result in a more reliable fabrication method (see Munoz pg. 148).
However the combination of references is silent regarding a conductive epoxy onto which a malleable metal is applied, and wherein the malleable metal with a thickness of at least about .5 microns.
In the same ultrasound field of endeavor, Toda teaches a conductive epoxy (fig. 1 matching layer 104 is a conductive epoxy [0025]) onto which a malleable metal is applied (fig. 1 protective layer 101 can be stainless steel which is a malleable metal and is applied on the matching layer 104 [0025]), and wherein the malleable metal with a thickness of at least about .5 microns. (fig. 1 the protective layer has a thickness of 900 microns, which is at least about .5 microns [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Munoz with the epoxy and malleable metal of Toda, as this would improve transmission efficiency and increase transducer bandwidth (see Toda [0024]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 1 above, and further in view of Hyuga et al., (US20090062656A1).
Regarding claim 17, modified Barlow teaches the assembly of claim 1, but fails to explicitly disclose wherein a wire electrode connector is attached to the backing layer in order to carry a current between the piezoelectric layer and an external electrode.
However in the same ultrasound field of endeavor, Hyuga teaches a wire electrode connector is attached to the backing layer in order to carry a current between the piezoelectric layer and an external electrode (fig. 6a the piezoelectric vibrator 2 is connected to a lead pad 15 via an electric wire 8 that is connected to the lower face of the backing material 1 that is external from the piezoelectric vibrator layer [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the wiring of Hyuga, as this would improve manufacturing yield and reduce costs (see Hyuga [0072]).
However the combination of references is silent regarding the conductive backing layer.
In the same ultrasound field of endeavor, Osawa teaches a conductive backing layer connecting to the piezoelectric layer (fig. 2 the transducer 1 is formed on the backing material 3, and the backing material 3 is made of an epoxy resin containing ferrite powder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify modified Barlow with the backing layer of Osawa, as this would quickly attenuate any unnecessary generated ultrasonic waves while suppressing lateral vibration of the transducers (see Osawa [0036]).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 1 above in further view of Munoz and as further evidenced by Zhao.
Regarding claim 21, modified Barlow teaches the assembly of claim 15, but fails to explicitly disclose wherein the metallic conductive layer is configured to transition acoustic impedances between the piezoelectric layer and an external environment outside of the catheter body.
However in the same ultrasound field of endeavor, Munoz teaches wherein the metallic conductive layer is configured to transition acoustic impedances between the piezoelectric layer and an external environment outside of the catheter body (fig. 4b the 1st matching layer is on top of the piezoelectric elements and would be between the piezoelectric layer and the target environment. In addition, the acoustic impedance of the piezoelectric layer is 35.88 MRayl, the acoustic impedance of the 1st matching layer is 7.33 MRayl and the external environment would be water, meaning that the matching layer gradually transitions the acoustics impedances from high to low pg. 149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the fabrication method of Munoz, as this would result in a more reliable fabrication method (see Munoz pg. 148). Further, Zhao teaches that the acoustic impedance of water is between about 1.5 MRayl to about 1.6 MRayl (see Zhao [0046]). This would result in the gradual transition from high acoustic impedance of the piezoelectric layer to low acoustic impedance of the water.
Regarding claim 22, modified Barlow teaches the assembly of claim 1, but fails to explicitly disclose an outermost protective layer over the piezoelectric layer and configured to transition an acoustic impedance between the piezoelectric layer and an external environment outside of the catheter body.
However in the same ultrasound field of endeavor, Munoz teaches wherein the metallic conductive layer is configured to transition acoustic impedances between the piezoelectric layer and an external environment outside of the catheter body (fig. 10 the 2nd matching layer is on top of the piezoelectric elements and 1st matching layer and would be between the piezoelectric layer and the target environment, In addition, the acoustic impedance of the piezoelectric layer is 35.88 MRayl, the acoustic impedance of the 1st matching layer is 7.33 MRayl, the impedance of the 2nd matching layer is 2.59 MRayl and the external environment would be water, meaning that the matching layer gradually transitions the acoustics impedances from high to low pg. 149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Barlow with the fabrication method of Munoz, as this would result in a more reliable fabrication method (see Munoz pg. 148). Further, Zhao teaches that the acoustic impedance of water is between about 1.5 MRayl to about 1.6 MRayl (see Zhao [0046]). This would result in the gradual transition from high acoustic impedance of the piezoelectric layer to low acoustic impedance of the water.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa as applied to claim 1 above, and further in view of Osawa and Tosaya et al., (US20060094988A1).
Regarding claim 23, modified Barlow teaches the assembly of claim 1, wherein Barlow teaches the central longitudinal axis of the catheter body (fig. 12 axis A) but fails to explicitly disclose a lateral protective layer about lateral side surfaces of the piezoelectric layer, the lateral protective layer configured to suppress lateral-mode vibrations .
In the same ultrasound field of endeavor, Osawa teaches a lateral protective layer about lateral side surfaces of the piezoelectric layer (fig. 2 the insulating resin is on the lateral side surface [0036]), the lateral protective layer configured to suppress lateral-mode vibrations (fig. 2 the insulating resin suppresses lateral vibration [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify modified Barlow with the lateral protective layer of Osawa as this would allow for efficient propagation of the ultrasonic waves (see Osawa [0037]).
However the combination of references is silent regarding directing ultrasound signals from the piezoelectric layer away from the body of the device
In the same ultrasound field of endeavor, Tosaya teaches directing ultrasound signals from the piezoelectric layer away from the body of the device (fig. 3a the waveguide 1b directs the ultrasonic waves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the lateral protective layer of modified Barlow to also include the waveguide as taught by Tosaya, as this would enhance the passage of acoustic waves (see Tosaya [0053]). This modification would then result in the protective layer directing ultrasound signals from the piezoelectric layer away from the central longitudinal axis of the catheter body.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Barlow as modified by Hutchins and Ozawa, Tosaya and Makin as applied to claim 23, and further in view of Kobayashi et al., (US20080129156A1) as further evidenced by Rothberg et al., (US20170360415A1).
Regarding claim 28, modified Barlow teaches the assembly of claim 13, but fails to explicitly the lateral protective layer.
However in the same ultrasound field of endeavor, Osawa teaches the lateral protective layer (fig. 2 the insulating resin suppresses lateral vibration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify modified Barlow with the lateral protective layer of Osawa as this would allow for efficient propagation of the ultrasonic waves (see Osawa [0037]).
However the combination of references still does not disclose the protective layer has a width of about a third of the thickness of the piezoelectric layer.
However in the same ultrasound field of endeavor, Kobayashi teaches the protective layer has a width of about a third of the thickness of the piezoelectric layer (fig. 1a the thickness of the partition wall 3 can be 20 μm (27 μm from Munoz)[0040]).
Though the combination of references do not specifically disclose that the thickness of the protective layer has a width of about a third of the piezoelectric layer, it would have been obvious to one of ordinary skill in the art to adjust the thickness of a layer to sufficiently suppress vibrations (as seen in Rothberg [0101] which discloses a relationship between thickness and vibration levels, i.e., thicker = less vibrations). As a result, through routine optimization, one of ordinary skill would be able to adopt the claimed width for the protective layer in order to suppress the lateral vibrations while not being too bulky so that it would interfere with operation of the transducer. This would result in the wall of modified Barlow having a thickness of about a third of the thickness of the piezoelectric layer would be predictable to one of ordinary skill in the art.
Claims 39 are rejected under 35 U.S.C. 103 as being unpatentable over Osawa in view of Wodnicki, and in further view of Douglas (US20160295319A1), Jacobs, and Hutchins.
Regarding 39, Osawa teaches a transducer for ultrasound measuring, the transducer comprising ([0019] invention is an ultrasound probe with a transducer):
a piezoelectric layer (fig. 3 the lower electrode layer, piezoelectric layer and the internal electrode layer is a piezoelectric element, which is considered as a piezoelectric layer [0039]) around a predetermined ultrasound wavelength and frequency (fig. 3 piezoelectric layers 12 are able to resonate, and would resonate at a wavelength and frequency[0039]); and
a backing layer directly connected to a bottom side of the piezoelectric layer (fig. 2 the transducer group 10 which include the piezoelectric layers 12 are formed on the backing material 3, [0036]).
However Osawa is silent regarding a conductive backing layer, wherein the conductive backing layer is configured to operate as a conductive electrode of the transducer.
In the same ultrasound field of endeavor, Douglas teaches a conductive backing layer connecting to the piezoelectric layer ([0090] the backing layer must conduct electricity; fig. 8B the piezoelectric elements is applied on the backing assembly 104), wherein the conductive backing layer is configured to operate as a conductive electrode of the transducer ([0090] “The backing layer must conduct electricity and provide an interconnection between a piezoelectric element and the PCB backing”; therefore the conductive backing layer would act as a conductive electrode for the transducer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify Osawa with the backing layer of Douglas, as this would enhance resolution and exhibit greater reliability and ease of manufacture (see Douglas [0006]).
However, the combination of references fail to explicitly disclose a thickness that produces about -20 dB or a more negative value of round-trip attenuation.
In the same ultrasound field of endeavor, Wodnicki teaches a thickness that produces about -20 dB or a more negative value of round-trip attenuation (pg. 392 the backing thickness, made of E-Solder 3022 is chosen so that the roundtrip attenuation would be greater than -40 dB).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the assembly of modified Osawa with the assembly of Wodnicki, as this would improve yield during the fabrication of the arrays and lower cost(pg. 388).
However the combination of references is still silent regarding the piezoelectric layer configured to resonate along an axis, wherein the predetermined ultrasound frequency is between 10 and 50 MHz.
In the same ultrasound field of endeavor, Jacobs teaches the piezoelectric layer is configured to resonate along an axis (see annotated fig. 12 the layer of transducer 442 would resonate along the annotated axis) wherein the predetermined ultrasound frequency is between 10 and 50 MHz (fig. 1 “the center frequency of the transducer array 110 can be between 10 MHz and 70 MHz, for example, including values such as 10 MHz, 20 MHz, 30 MHz, 40 MHz, 45 MHz, 60 MHz, and/or other suitable values” [0036]).
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However the combination of references is still silent regarding wherein the piezoelectric layer has a width to thickness ratio between 2 and 7 and wherein the thickness of the piezoelectric layer is measured along the axis.
In the same ultrasound field of endeavor, Hutchins teaches wherein the piezoelectric layer has a width to thickness ratio between 2 and 7 (fig. 3a the height of the piezoelectric stack of ultrasound transducer 55 is 80 microns and the width is 300 microns, which is width to thickness ratio of 3.75 [0074]) and wherein the thickness of the piezoelectric layer is measured along the axis (see annotated fig. 3a the thickness t is measured along the axis).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the width to thickness ratio of the piezoelectric assembly of modified Jacobs with the width to thickness ratio of the piezoelectric structure of Hutchins, as both inventions relate to ultrasound devices and would yield the predictable result of an ultrasound device having a width to thickness ratio of 3.75 wherein the thickness of the piezoelectric layer is measured along the axis to one of ordinary skill in the art. One of ordinary skill would be able to make sure a substitution, and the results of the modified Jacobs having a piezoelectric structure with a width to thickness ratio of 3.75 are reasonable predictable.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Osawa as modified by Douglas, Wodnicki, Jacobs, and Hutchins as applied to claim 39 and further evidenced by Makin.
Regarding claim 40, modified Osawa teaches the transducer of claim 39, wherein Osawa further teaches the conductive backing material but fails to explicitly disclose a rigid body over which the backing layer is positioned, the rigid body assembled for encompassing a central longitudinal axis of an acoustic probe body, wherein the rigidity of the rigid body is configured to attenuate ultrasound signals directed toward the central longitudinal axis of the acoustic probe body and to direct ultrasound signals away from the central longitudinal axis of the acoustic probe body.
However in the same ultrasound field of endeavor, Jacobs teaches a rigid body over which the backing layer is positioned (fig. 4 support member 230 is stainless steel [0049]; support member 230 has backing material 246 positioned overtop [0050]), the rigid body assembled for encompassing a central longitudinal axis of an acoustic probe body (fig. 4 support member 230 encompasses lumen 236 for intraluminal device 102 [0049]),
wherein a rigidity of the rigid body is configured to attenuate ultrasound signals directed toward the central longitudinal axis of the catheter body and to direct ultrasound signals away from the central longitudinal axis of the catheter body (fig. 2 the support member 230 is composed of metallic material such as stainless steel, and which, due to its rigidity, would be able to attenuate ultrasound signals directed toward the central longitudinal axis of the catheter body and direct ultrasound signals away from the central longitudinal axis of the catheter body [0048]; this is evidenced by Makin in paragraph [0048], which states that stainless steel reflects about 100% of ultrasound waves and can direct ultrasound back).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the transducer of modified Osawa with the support member of Jacobs, as this would advantageously allow the outer profile of the control circuits to be reduced (see Jacobs [0058]).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Osawa as modified by Douglas, Wodnicki, Jacobs, and Hutchins as applied to claim 39, and further in view of Munoz.
Regarding claim 43, modified Osawa teaches the transducer of claim 39, but fails to explicitly disclose a metallic conductive matching layer positioned over a top side of the piezoelectric layer, wherein the metallic conductive matching layer has a thickness of less than about a quarter of a resonant wavelength of a material of the matching layer.
However in the ultrasound field of endeavor, Munoz teaches a metallic conductive matching layer positioned over a top side of the piezoelectric layer (fig. 4B the piezoelectric elements where sputtered with a metallic layer (pg. 149) and ends with the 1st matching layer laid upon it resulting in a 202 composite and 1st matching layer), wherein the metallic conductive matching layer has a thickness of less than about a quarter of a resonant wavelength of a material of the matching layer (Table 1 the frequency of the transducer is 30 MHz and the thickness of the 1st matching layer is 25 µm, Table 2 the acoustic velocity in silver epoxy is 1900m/s; therefore the resonant wavelength of silver epoxy is 63.3 µm pg. 147, 25 µm is about a quarter of the 63.3333 µm wavelength).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the transducer of modified Osawa with the matching layer of Munoz, as this would result in a more reliable fabrication method (see Munoz pg. 148).
Response to Arguments
Applicant’s arguments with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument Barlow in view of Hutchins and Ozawa have been used to teach the limitations of claim
Applicant's arguments filed 07/30/2025 have been fully considered but they are not persuasive.
Regarding claim 39, Applicant argues that one of ordinary skill would not be able to modify Osawa’s existing electrical interconnection structures with the conductive backing material of Douglas and that the modification would change the principle of operation of the device.
Examiner disagrees, as the exclusion of the backing material from electrical connection is not the core principle of operation for Osawa, and instead is the operation of the multilayer piezoelectric array with conductive interconnects to improve array performance. While Osawa uses conductive resin layers for interconnection, nothing in Osawa makes an electrically inactive backing essential to its operation. The core principle of operation of Osawa, that being a ultrasonic probe with multiple piezoelectric layers and electrical interconnections and acoustic dampening, remains the same if the backing is made conductive and functions as the rear electrode. Douglas reinforces this idea, as one of ordinary skill would recognize it as a reasonably predictable and routine substitution. Osawa even points to conductive backing material, such as the metal and PZT powder, and so using Douglas to explicitly teach a conductive backing and modifying Osawa would be reasonably for one of ordinary skill in the art.
Further, one of ordinary skill would be motivated to combine the transducer assembly of Osawa with the conductive backing material of Douglas, as this would help to enhance resolution and improve reliability and ease of manufacturing (Douglas [0006]).
For the reasons above, claims 1 and 39 remain rejected.
The remaining dependent claims are rejected for substantially the same reasons as above.
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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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798