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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/14/2026 has been entered.
Response to Amendment
Claims 1, 2, and 5-20 are pending.
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.
Claims 1, 2, 12, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al., (US 20190053785 A1) in view of Eberle et al., (US6618916B1).
Regarding claim 1, Stigall teaches an intraluminal imaging device, comprising (Abstract intraluminal ultrasound device):
a flexible elongate member (fig. 1 flexible elongate member 216) configured to be positioned within a body lumen of a patient (Abstract intraluminal ultrasound device), wherein the flexible elongate member comprises a longitudinal axis (fig. 1 LA [0023]);
an ultrasound imaging assembly (fig. 1 transducer assembly 200) disposed at a distal portion of the flexible elongate member, wherein the ultrasound imaging assembly comprises (fig. 1 the transducer assembly 200 is on the distal end of elongate member 216):
a flexible substrate (fig. 2B flex substrate 214) comprising a plurality of conductive traces (fig. 2B traces 216), wherein the flexible substrate is disposed around a circumference of the flexible elongate member (fig. 3B flex substrate 214 is disposed around circumference of transducer assembly 200); and
a transducer array disposed on the flexible substrate such that the transducer array is disposed around the circumference of the flexible elongate member (fig. 3B transducer array 304 (A and B) is disposed around the circumference of the transducer assembly 200), wherein the transducer array comprises a plurality of rows and a plurality of columns (fig. 3B there are two rows and a plurality of columns), wherein each column comprises a plurality of transducer elements disposed along the longitudinal axis such that the plurality of transducer elements corresponds to the plurality of rows (fig. 3B each transducer of 304A corresponds to a different transducer of 304B),
wherein the plurality of transducer elements comprises a bottom surface proximate to the flexible substrate (fig. 3B the side of the transducer that is touching the flex substrate 214 is the first surface) and a top surface spaced from the flexible substrate (fig. 3B the other side not touching the flex substrate 214 is the second surface), and
wherein the plurality of transducer elements are electrically coupled to the plurality of conductive traces only on the bottom surface (fig. 2B conductive trace 216 is formed on a film layer of the flex substrate 216 ([0052]) and carries signals from the transducers 212) such that multiple conductive traces (fig. 2B the traces 216 are connected to the plurality of transducer elements 212) are configured to provide communication of electrical signals associated with ultrasound imaging ([0053] the traces 216 carry signals between the control logic dies 206 and the transducers 212).
However, Stigall is silent regarding each transducer elements of the plurality of transducer elements are electrically coupled to multiple ones of the plurality of conductive traces only on the bottom surface such that the multiple conductive traces are configured to provide communication of electrical signals associated with ultrasound imaging, and wherein the bottom electrode is electrically coupled to an individual conductive trace of the multiple conductive traces that are coupled to the individual transducer elements.
In the same ultrasound field of endeavor, Eberle teaches each transducer elements of the plurality of transducer elements are electrically coupled to multiple ones of the plurality of conductive traces (fig. 6 each transducer 8 comprises a PZT composite 40 that is connected to signal lines 34 and electrical lines 44 and are the bottom of the surface 44 col. 10 34-36) only on the bottom surface (fig. 6 the lines 34 and 44 are on the bottom side of the PZT composite 40) such that the multiple conductive traces are configured to provide communication of electrical signals associated with ultrasound imaging (the signal lines 34 provide the ultrasound signals and the ground lines 44 would provide communication for any faulty electrical signals used for ultrasound imaging), and wherein the bottom electrode is electrically coupled to an individual conductive trace of the multiple conductive traces that are coupled to the individual transducer elements (fig. 6 the signal lines 34 terminate at signal contacts 48).
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 electrodes and transducer elements of modified Stigall with the plurality of transducers elements being coupled to multiple conductive traces of Eberle, as this would reduce complexity because conductive bridges between flexible circuit lines and electrodes located on a physically remote surface of the transducer elements are no longer required (see Eberle col. 2 lines 59-60 and col. 3 lines 15-18).
Regarding claim 2, modified Stigall teaches the device of claim 1, but is silent regarding wherein a quantity of the plurality of transducer elements is N and a quantity of the plurality of conductive traces is N+1.
However, Stigall does teach of conductive traces that are electrically connected to the plurality of transducers (fig. 2B traces 216). One of ordinary skill in the art would understand that this a merely a design choice with a duplication of parts of the conductive traces, and has no patentable significance as no new and unexpected result has been produced. As such, one of ordinary skill in the art would be able to consider a quantity of the plurality of transducer elements is N and a quantity of the plurality of conductive traces is N+1 without the exercise of inventive skill.
Regarding claim 12, modified Stigall teaches the device of claim 1, wherein Stigall further teaches wherein the transducer array comprises gaps between the plurality of transducer elements (fig. 2B there are gaps between each transducer 212).
Regarding claim 13, modified Stigall teaches the device of claim 1, but is silent regarding wherein the ultrasound imaging assembly further comprises material disposed between side surfaces of the plurality of transducer elements such that no gaps are between the plurality of transducer elements.
However in the same ultrasound field of endeavor, Eberle teaches wherein the ultrasound imaging assembly further comprises material disposed between side surfaces of the plurality of transducer elements such that no gaps are between the plurality of transducer elements (fig. 4 the backing material 30 fills in the gaps between the transducers 8 col. 9 lines 42-44).
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 device of Stigall with the backing material of Eberle, as this would provide sufficient support for the transducer elements (see Eberle col. 7 lines 60-62).
Regarding claim 20, Stigall teaches an intravascular ultrasound (IVUS) imaging device (Abstract intraluminal ultrasound device) comprising:
a catheter (fig. 1 ultrasound device 110 can be a catheter) configured to be positioned within a blood vessel of a patient (Abstract intraluminal ultrasound device), wherein the flexible elongate member comprises a longitudinal axis (see annotated fig. 1);
an IVUS imaging assembly (fig. 1 transducer assembly 200) disposed at a distal portion of the catheter, wherein the IVUS imaging assembly comprises (fig. 1 the transducer assembly 200 is on the distal end of elongate member 216):
a flexible substrate (fig. 2B flex substrate 214) comprising a plurality of conductive traces (fig. 2B traces 216), wherein the flexible substrate is disposed around a circumference of the catheter (fig. 3B flex substrate 214 is disposed around circumference of transducer assembly 200 of ultrasound device 110); and
a transducer array disposed on the flexible substrate such that the transducer array is disposed around the circumference of the flexible elongate member (fig. 3B transducer array 304 (A and B) is disposed around the circumference of the transducer assembly 200), wherein the transducer array comprises a plurality of rows and a plurality of columns (fig. 3B there are two rows and a plurality of columns), wherein each column comprises a plurality of transducer elements disposed along the longitudinal axis such that the plurality of transducer elements corresponds to the plurality of rows (fig. 3B each transducer of 304A corresponds to a different transducer of 304B),
wherein the plurality of transducer elements comprises a bottom surface proximate to the flexible substrate (fig. 3B the side of the transducer that is touching the flex substrate 214 is the first surface) and a top surface spaced from the flexible substrate (fig. 3B the other side not touching the flex substrate 214 is the second surface), and
wherein the plurality of transducer elements are electrically coupled to the plurality of conductive traces only on the bottom surface (fig. 2B conductive trace 216 is formed on a film layer of the flex substrate 216 ([0052]) and carries signals from the transducers 212).
However, Stigall fails to explicitly disclose the bottom surface comprises a bottom electrode.
In the same ultrasound field of endeavor, Eberle teaches the bottom surface comprises a bottom electrode (fig. 6 the signal lines 34 terminate at signal contacts 48 col. 10 64-67; the signal contacts are on the bottom side of the PZT composite 40)
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 electrodes and transducer elements of Stigall with the electrodes of Eberle, as this would reduce complexity because conductive bridges between flexible circuit lines and electrodes located on a physically remote surface of the transducer elements are no longer required (see Eberle col. 2 lines 59-60 and col. 3 lines 15-18).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall as modified by Eberle as applied to claim 1 above, and further in view of Panescu et al., (US20040015065A1).
Regarding claim 5, modified Stigall teaches the device of claim 1, but fails to explicitly disclose wherein the plurality of conductive traces comprises a single conductive trace at electrical ground and electrically coupled to each transducer element of plurality of transducer elements.
However, in the same ultrasound field of endeavor, Panescu teaches wherein the plurality of conductive traces comprises a single conductive trace at electrical ground and electrically coupled to each transducer element of plurality of transducer elements (fig. 5A a ground 52 is a common ground that is used for all transducer elements 28).
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 device of Stigall with the ground of Panescu, as this would lead to fewer leads or wires (see Panescu [0041]).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall as modified by Eberle and Panescu as applied to claim 5 above, and further in view of Sudol et al., (US20140139072A1)
Regarding claim 6, modified Stigall teaches the device of claim 5, but fails to explicitly disclose wherein the top surface comprises a top electrode electrically coupled to the single conductive trace.
In the same ultrasound field of endeavor, Sudol teaches wherein the top surface comprises a top electrode electrically coupled to the single conductive trace (fig. 1 the top of piezoelectric layer 110 is electrically coupled to the ground wire of flex circuit 185 [0029] and [0035]).
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 device of modified Stigall with the connections of Sudol, as this would make the manufacturing process easy (see Sudol [0029]).
Regarding claim 7, modified Stigall teaches the device of claim 6, but fails to explicitly disclose wherein the plurality of transducer elements comprises: a side surface between the top surface and the bottom surface, wherein the side surface comprises a conductive material electrically coupled to the top electrode and the single conductive trace.
In the same ultrasound field of endeavor, Sudol teaches wherein the plurality of transducer elements comprises: a side surface between the top surface and the bottom surface, wherein the side surface comprises a conductive material electrically coupled to the top electrode and the single conductive trace (fig. 1 conductive layer 125 connects the top electrode layer 112a to the bottom electrode layer 111 and to the ground, and can be on at least one, meaning it can be on a plurality of transducer elements [0029]).
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 device of modified Stigall with the conductive layer of Sudol, as this would provide a short electrical path and make the manufacturing process easy (see Sudol [0029]).
Regarding claim 8, modified Stigall teaches the device of claim 7, but fails to explicitly disclose wherein the ultrasound imaging assembly further comprises a single electrical connection for the plurality of transducer elements providing the electrical ground via the single conductive trace.
In the same ultrasound field of endeavor, Sudol teaches wherein the ultrasound imaging assembly further comprises a single electrical connection for the plurality of transducer elements providing the electrical ground via the single conductive trace (fig. 1 conductive connector 200 connects the transducer elements to the flex circuit 125 which has the electrical ground [0034] and [0035]).
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 device of modified Stigall with the conductive layer of Sudol, as this would provide an easier manufacturing and thus a cheaper ultrasound transducer assembly (see Sudol [0003]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall as modified by Eberle, Panescu and Sudol as applied to claim 7 above, and further in view of Brock-Fisher et al., (US 20160296207 A1)
Regarding claim 9, modified Stigall teaches the device of claim 7, but fails to explicitly disclose wherein the bottom surface comprises: a first bottom electrode portion in electrical communication with the side surface, the top electrode, and the single conductive trace; and a second bottom electrode portion isolated from the first bottom electrode portion by a discontinuity.
However, in the same ultrasound field of endeavor, Sudol teaches wherein the bottom surface comprises: a first bottom electrode portion in electrical communication with the side surface, the top electrode, and the single conductive trace (fig. 1 conductive layer 125 is in electrical communication with electrode 111a , 112a, and the ground connection portion of the flex circuit 185 [0035]); and a second bottom electrode portion isolated from the first bottom electrode portion by a discontinuity (fig. 1 bottom electrode layers 111 are isolated from the electrode layer 111a).
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 device of modified Stigall with the electrodes of Sudol, as this would provide an easier manufacturing and thus a cheaper ultrasound transducer assembly (see Sudol [0003]).
However, the combination of references are silent regarding a second bottom electrode portion electrically isolated.
In the same ultrasound field of endeavor, Brock-Fisher teaches a second bottom electrode portion electrically isolated (fig. 3 each transducer element 54 comprises a bottom electrode 70 that is in an isolated layer 72).
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 bottom electrodes of modified Stigall to be electrically isolated like in Brock-Fisher, as this would increase transmit efficiency and an increased receive signal to noise ratio with low technical effort (see Brock-Fisher [0006]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall as modified by Eberle, Panescu and Sudol as applied to claim 7 above, and further in view of Ossmann (US20060150380A1).
Regarding claim 10, modified Stigall teaches the device of claim 7, wherein Stigall further teaches wherein a first transducer element of the plurality of transducer elements and a second transducer element of the plurality of transducer elements are adjacent to one another (fig 3b the transducer 212a is adjacent to transducer 212b), but fails to explicitly disclose wherein the conductive material on the side surface of the first transducer element is proximate to the conductive material on the side surface of the second transducer element.
However in the same ultrasound field of endeavor, Ossmann teaches wherein the conductive material on the side surface of the first transducer element is proximate to the conductive material on the side surface of the second transducer element (fig. 5 element metallization layer 22 are on the sides of the transducer elements 10a, and are proximate to each other).
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 device of modified Stigall with the conductive material of Ossmann, as his would optimize the acoustic performance of the transducer with an incorporated electronic circuit (see Ossmann [0022]).
Regarding claim 11, modified Stigall teaches the device of claim 10, but fails to explicitly disclose comprising a single electrical connection electrically coupled to the conductive material on the side surface of the first transducer element and to the conductive material on the side surface of the second transducer element.
However in the same ultrasound field of endeavor, Ossmann teaches comprising a single electrical connection electrically coupled to the conductive material on the side surface of the first transducer element and to the conductive material on the side surface of the second transducer element (fig. 4 conductor 24 is electrically coupled to the element metallization layers 22 [0052]).
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 device of modified Stigall with the conductive material of Ossmann, as his would optimize the acoustic performance of the transducer with an incorporated electronic circuit (see Ossmann [0022]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall as modified by Eberle as applied to claim 13 above, and further in view of Panescu and Mamayek et al., (US 6113546 A).
Regarding claim 14, modified Stigall teaches the device of claim 13, but is silent regarding wherein the plurality of conductive traces comprises a single conductive trace at electrical ground,
However, in the same ultrasound field of endeavor, Panescu teaches wherein the plurality of conductive traces comprises a single conductive trace at electrical ground (fig. 5A a ground 52 is a common ground that is used for all transducer elements 28).
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 device of modified Stigall with the ground of Panescu, as this would lead to fewer leads or wires (see Panescu [0041]).
However, the combination of references are still silent regarding wherein the material is conductive and electrically coupled to the single conductive trace such that the material provides the electrical ground to the plurality of transducer elements.
In the same ultrasound field of endeavor, Mamayek teaches wherein the material is conductive (col. 5 line 44-46 the backing material is electrically conductive) and electrically coupled to the single conductive trace such that the material provides the electrical ground to the plurality of transducer elements (col. 5 line 47-50 the backing material provides a back side ground to the electrode attached to the transducer element 14).
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 material of modified Stigall with the backing material of Mamayek, as this would improve overall performance of the transducer (see Mamayek col. 3 line 1-3).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall in view of Guo as applied to claim 1 above, and further in view of Dausch et al., (US 20100168583 A1)
Regarding claim 15, Stigall teaches the device of claim 1, but fails to explicitly disclose wherein top electrode that is continuous across the plurality of transducer elements.
In the same ultrasound field of endeavor, Dausch teaches wherein top electrode electrically coupled to the single conductive trace (fig. 6 the top electrode 32 is continuous across the plurality of piezoelectric array elements 22 [0048])
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 device of Stigall with the top electrode of Dausch, as this would offer functional and fabrication advantages (see Dausch [0012]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall in view of Eberle as applied to claim 1 above, and further in view of Haider et al., (US 20080183078 A1).
Regarding claim 16, Stigall teaches the device of claim 1, but fails to explicitly disclose wherein the ultrasound imaging assembly further comprises a plurality of solder bumps electrically coupling the plurality of transducer elements and the plurality of conductive traces.
However in the same ultrasound field of endeavor, Haider teaches wherein the ultrasound imaging assembly further comprises a plurality of solder bumps electrically coupling the plurality of transducer elements and the plurality of conductive traces (fig. 2 the solder bumps 278 connects each transducer element 136 to the conductive trace 222).
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 device of Stigall with the soldering of Haider, as this would allow for the reduction of size and weight of probes while improving image quality (see Haider [0006]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall in view of Eberle as applied to claim 1 above, and further in view of Tarakci et al., (US20020138002A1).
Regarding claim 17, modified Stigall teaches the device of claim 1, but fails to explicitly disclose wherein the ultrasound imaging assembly further comprises an anisotropic conductive material electrically coupling the plurality of transducer elements and the plurality of conductive traces.
However in the same ultrasound field of endeavor, Tarakci teaches wherein the ultrasound imaging assembly further comprises an anisotropic conductive material electrically coupling the plurality of transducer elements and the plurality of conductive traces (fig. 3 the intermediate elements 306 may be an electrically anisotropic conducting media that connects the transducing elements 312 and the electrical pads 304).
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 device of modified Stigall to use anisotropic electrical conductors, as this would reduce the chances of shorting between adjacent elements (see Tarakci [0055]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall in view of Eberle as applied to claim 1 above, and further in view of Wakabayashi et al., (US 20080084137 A1).
Regarding claim 18, modified Stigall teaches the device of claim 1, but fails to explicitly disclose wherein the ultrasound imaging assembly further comprises a conductive material layer electrically coupling the plurality of transducer elements and the plurality of conductive traces.
However in the same ultrasound field of endeavor, Wakabayashi teaches wherein the ultrasound imaging assembly further comprises a conductive material layer electrically coupling the plurality of transducer elements and the plurality of conductive traces (fig. 4 b the conductive layer 7300 connections the transducers with the respective signal wires [0022]-[0023]).
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 device of modified Stigall with the conductive layer of Wakabayashi, as this would make wiring work smooth and easier to position (see Wakabayashi [0024]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Stigall in view of Eberle as applied to claim 1 above, and further in view of Panescu and Fuller et al., (US 20070261494 A1).
Regarding claim 19, modified Stigall teaches the device of claim 1, but is silent regarding wherein the plurality of conductive traces comprises a single conductive trace at electrical ground,
However, in the same ultrasound field of endeavor, Panescu teaches wherein the plurality of conductive traces comprises a single conductive trace at electrical ground (fig. 5A a ground 52 is a common ground that is used for all transducer elements 28).
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 device of modified Stigall with the ground of Panescu, as this would lead to fewer leads or wires (see Panescu [0041]).
However, the combination of references are still silent regarding a conductive layer disposed on the top surface, wherein the conductive layer is electrically coupled to the single conductive trace such that the conductive layer provides the electrical ground to the plurality of transducer elements.
In the same ultrasound field of endeavor, Fuller teaches a conductive layer disposed on the top surface (fig. top plating layer 45 [0046]), wherein the conductive layer is electrically coupled to the single conductive trace such that the conductive layer provides the electrical ground to the plurality of transducer elements ([0046] the top plating layer is in electrical communication with the electrical ground member 65 that is connected with the transducer layer 50).
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 device of modified Stigall with the conductive layer of Fuller, as this would develop a simple but more accurate method for detection (see Fuller [0004]).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 20 have 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. The claims are now rejected by Stigall in view of Eberle.
The remaining dependent claims are rejected for the same reasons as above.
Conclusion
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798