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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/29/2025 has been entered.
Response to Amendment
This office action is in response to the communications filed on 08/04/2025 and 08/29/2025, concerning Application No. 18/633,736. The amendments to the claims filed on 08/04/2025 are acknowledged. Presently, claims 1-18 are pending.
Claim Objections
Claims 1-4 and 16-18 are objected to because of the following informalities:
Claims 1-4 and 16-18, each recitation of the limitation “the support member” should be changed to “the singular rigid support member” to maintain consistent terminology throughout the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eberle et al. (US Patent No. 5,857,974 A, hereinafter Eberle).
Regarding claim 1, Eberle discloses an apparatus, comprising: an intravascular ultrasound (IVUS) catheter (see, e.g., Figs. 1-7 and 12) comprising:
a flexible elongate member comprising a distal portion configured to be inserted into a blood vessel of a patient and a proximal portion (see, e.g., Figs. 1-7 and 12, and Abstract, and Col. 1, lines 65-67 and Col. 2, lines 1-8, “a new technique has been developed for obtaining information about coronary vessels and to view the effects of therapy on the form and structure of a site within a vessel rather then merely determining that blood is flowing through a vessel. The new technique, known as Intracoronary/Intravascular Ultrasound (ICUS/IVUS), employs very small transducers arranged on the end of a catheter which provide electronic transduced echo signals to an external imaging system in order to produce a two or three-dimensional image of the lumen, the arterial tissue, and tissue surrounding the artery”, and Col. 14, lines 36-60, “Turning now to FIGS. 12 and 13, an illustrative example of the typical environment and application of an ultrasound device embodying the present invention is provided. Referring to FIGS. 12 and 13, a buildup of fatty material or plaque 70 in a coronary artery 72 of a heart 74 may be treated in certain situations by inserting a balloon 76, in a deflated state, into the artery via a catheter assembly 78. As illustrated in FIG. 12, the catheter assembly 78 is a three-part assembly, having a guide wire 80, a guide catheter 78a for threading through the large arteries such as the aorta 82 and a smaller diameter catheter 78b that fits inside the guide catheter 78a. After a surgeon directs the guide catheter 78a and the guide wire 80 through a large artery leading via the aorta 82 to the coronary arteries, the smaller catheter 78b is inserted. At the beginning of the coronary artery 72 that is partially blocked by the plaque 70, the guide wire 80 is first extended into the artery, followed by catheter 78b, which includes the balloon 76 at its tip. After the balloon 76 has entered the coronary artery 72, as in FIG. 13, an ultrasonic imaging device including a probe assembly 84 housed within the proximal sleeve 86 of the balloon 76 provides a surgeon with a cross-sectional view of the artery on a video display 88. In the illustrated embodiment of the invention, the transducers emit 20 MHz ultrasound excitation waveforms”); and
a flexible assembly (flex circuit 2) positioned at the distal portion of the flexible elongate member (see, e.g., Figs. 1-5, and Col. 4, lines 60-67, “Turning now to FIG. 1, an ultrasound transducer assembly is illustratively depicted in its flat form in which it is assembled prior to forming the device into its final, cylindrical form. The ultrasound transducer assembly comprises a flex circuit 2, to which the other illustrated components of the ultrasound transducer assembly are attached. The flex circuit 2 preferably comprises a flexible polyimide film layer (substrate) such as KAPTON.TM. by DuPont”) and comprising:
a flexible substrate (KAPTON substrate 33) (see, e.g., Figs. 5 and 5a, and Col. 4, lines 65-67, “The flex circuit 2 preferably comprises a flexible polyimide film layer (substrate) such as KAPTON.TM. by DuPont”, and Col. 9, lines 10-19, “Turning now to FIGS. 5 and 5a, a cross-sectional view and enlarged partial cross-sectional view are provided of the ultrasound transducer assembly illustrated in FIG. 2 sectioned along line 5--5 and running along the length of the ultrasound transducer assembly embodying the present invention. A KAPTON substrate 33 portion of the flex circuit 2, approximately 13 .mu.m in thickness, completely surrounds the ultrasound transducer assembly, acts as an acoustic matching layer and protects the electronic components of the ultrasound transducer assembly”);
a transducer array (transducer elements 8, transducer portion 12) coupled to the flexible substrate (33) (see, e.g., Figs. 1-2, 4-5, and 5a, and Col. 3, lines 3-6, “An ultrasound transducer array and integrated circuitry are attached during fabrication of the ultrasound transducer assembly while the flexible substrate is substantially planar (i.e., flat)”, and Col. 5, lines 9-13, “The interconnection circuitry comprises conductor lines deposited upon the surface of the flex circuit 2 between a set of five (5) integrated circuit chips 6 and a set of sixty-four (64) transducer elements 8 made from PZT or PZT composites”, and Col. 9, lines 10-19, “Turning now to FIGS. 5 and 5a, a cross-sectional view and enlarged partial cross-sectional view are provided of the ultrasound transducer assembly illustrated in FIG. 2 sectioned along line 5--5 and running along the length of the ultrasound transducer assembly embodying the present invention. A KAPTON substrate 33 portion of the flex circuit 2, approximately 13 .mu.m in thickness, completely surrounds the ultrasound transducer assembly, acts as an acoustic matching layer and protects the electronic components of the ultrasound transducer assembly”); and
a plurality of control circuits (integrated circuit chips 6, electronics portion 14) coupled to the flexible substrate (33) (see, e.g., Figs. 1-3, 5, and 5a, and Col. 3, lines 3-6, “An ultrasound transducer array and integrated circuitry are attached during fabrication of the ultrasound transducer assembly while the flexible substrate is substantially planar (i.e., flat)”, and Col. 5, lines 9-13, “The interconnection circuitry comprises conductor lines deposited upon the surface of the flex circuit 2 between a set of five (5) integrated circuit chips 6 and a set of sixty-four (64) transducer elements 8 made from PZT or PZT composites”, and Col. 9, lines 10-19, “Turning now to FIGS. 5 and 5a, a cross-sectional view and enlarged partial cross-sectional view are provided of the ultrasound transducer assembly illustrated in FIG. 2 sectioned along line 5--5 and running along the length of the ultrasound transducer assembly embodying the present invention. A KAPTON substrate 33 portion of the flex circuit 2, approximately 13 .mu.m in thickness, completely surrounds the ultrasound transducer assembly, acts as an acoustic matching layer and protects the electronic components of the ultrasound transducer assembly”); and
a singular rigid support member (lumen tube 18) (see, e.g., Col. 6, lines 51-67 and Col. 7, lines 1-2, “A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium. The radiopaque material assists in locating the ultrasound transducer assembly within the body during a medical procedure incorporating the use of the ultrasound transducer assembly. As will be explained further below, the conductive property of the lumen tube 18 offers a means for connecting the transducer ground electrodes to a ground wire included in at least one of the wires connected to the cable pads 10. Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30”, where the disclose lumen tube 18 is taught to be a singular tube made of a thin radiopaque, conductive material such as Platinum/Iridium, such that the materials platinum and iridium are known in the art to be relatively stiff/hard/rigid materials) comprising an outer profile (surface profile of backing material 30) and a plurality of recessed surfaces that are recessed relative to the outer profile (see, e.g., Col. 6, lines 51-67 and Col. 7, lines 1-25, “A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium. […] Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30. […] Turning now to FIG. 3, a cross-section view is provided of the ultrasound transducer assembly taken along line 3--3 and looking toward the transducer portion 12 in FIG. 2. The outside of the electronics portion 14 has a pentagon shape. The circular outline 26 represents the outside of the transducer portion 12. The flex circuit 2 encompasses the cylindrically shaped ultrasound transducer assembly. The backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18. While relatively soft, the backing material 30 provides a satisfactory measure of structural support to the integrated circuit chips 6 in the final assembly of the ultrasound transducer assembly”, and Figs. 3 and 5, where backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18, and where the outer profile/surface of the backing material 30 is shown to be the surface adjacent to the inner side of the flex circuit 2, and where the backing material 30 is shown to comprise recessed/cavity sections (i.e., five cavities as shown in Fig. 3) where the integrated circuit chips 6 are shown to be positioned/received within, such that the recessed/cavity sections are positioned recessed relative to the outer profile/surface of the backing material),
wherein the flexible assembly (2) is wrapped around the support member (18) (see, e.g., Col. 6, lines 51-58, “FIG. 2 also shows the set of cable pads 10 on the flex circuit 2 extending from the portion of the flex circuit 2 supporting the integrated circuit chips 6. A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium”, and Figs. 2-5, where the flex circuit 2 is shown to be positioned over/wrapped around the lumen tube 18 and the backing material 30) such that the plurality of control circuits (6) is positioned and received within the plurality of recessed surfaces (see, e.g., Col. 6, lines 66-67 and Col. 7, lines 1-25, “Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30. In contrast to earlier ultrasound catheter assembly designs including a relatively hard carrier material such as a rigid encapsulating epoxy, the backing material 30 that fills the spaces between the lumen tube 18 and the integrated circuit chips 6 is relatively soft. […] The backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18. While relatively soft, the backing material 30 provides a satisfactory measure of structural support to the integrated circuit chips 6 in the final assembly of the ultrasound transducer assembly”, and Figs. 3 and 5, where the integrated circuit chips 6 are shown to be positioned/received within the recessed/cavity sections (i.e., five cavities as shown in Fig. 3) of the backing material 30).
Regarding claim 2, Eberle discloses the apparatus of claim 13. Eberle further discloses wherein the support member (lumen tube 18 and backing material 30) is distinct from the base substrate (two-part epoxy bonds 38), the flexible substrate (KAPTON substrate 33), and the plurality of control circuits (integrated circuit chips 6) (see, e.g., Col. 6, lines 51-58, “FIG. 2 also shows the set of cable pads 10 on the flex circuit 2 extending from the portion of the flex circuit 2 supporting the integrated circuit chips 6. A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium”, and Col. 9, lines 36-37, “Two-part epoxy 38 bonds the integrated circuit chips 6 to the flex circuit 2”, and Figs. 2-5, where the flex circuit 2 including the two-part epoxy bonds 38, the KAPTON substrate 33, and the integrated circuit chips 6 is shown to be positioned over/wrapped around the outer surface of the lumen tube 18 and the backing material 30, and are each shown to be distinct components from one another).
Regarding claim 3, Eberle discloses the apparatus of claim 2. Eberle further discloses wherein the plurality of control circuits (integrated circuit chips 6) is positioned over the flexible substrate (KAPTON substrate 33), the base substrate (two-part epoxy bonds 38), and the support member (lumen tube 18 and backing material 30), wherein the flexible substrate (33) is positioned over the base substrate (38) and the support member (18, 30), and wherein the base substrate (38) is positioned over the support member (18, 30) (see, e.g., Figs. 5 and 5a, where the integrated circuit chips 6 are shown to be positioned over each of the two-part epoxy bonds 38, the KAPTON substrate 33, and the lumen tube 18/backing material 30, and where the KAPTON substrate 33 is shown to be positioned over each of the two-part epoxy bonds 38 and the lumen tube 18/backing material 30, and where the two-part epoxy bonds 38 is shown to be positioned over the lumen tube 18/backing material 30).
Regarding claim 4, Eberle discloses the apparatus of claim 1. Eberle further discloses wherein the support member (lumen tube 18 and backing material 30) comprises a lumen (lumen 16) configured to receive a guidewire (see, e.g., Figs. 2-5, and Col. 6, lines 51-58, “FIG. 2 also shows the set of cable pads 10 on the flex circuit 2 extending from the portion of the flex circuit 2 supporting the integrated circuit chips 6. A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium”), and wherein the plurality of recessed surfaces is positioned around the lumen (16) (see, e.g., Col. 6, lines 51-67 and Col. 7, lines 1-25, “A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium. […] Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30. In contrast to earlier ultrasound catheter assembly designs including a relatively hard carrier material such as a rigid encapsulating epoxy, the backing material 30 that fills the spaces between the lumen tube 18 and the integrated circuit chips 6 is relatively soft. […] The backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18. While relatively soft, the backing material 30 provides a satisfactory measure of structural support to the integrated circuit chips 6 in the final assembly of the ultrasound transducer assembly”, and Figs. 3 and 5, where the integrated circuit chips 6 are shown to be positioned/received within the recessed/cavity sections (i.e., five cavities as shown in Fig. 3) of the backing material 30, such that the integrated circuit chips 6 received within the recessed/cavity sections are shown to be positioned over/wrapped around the outer surface of the lumen tube 18 and the backing material 30).
Regarding claim 5, Eberle discloses the apparatus of claim 13. Eberle further discloses wherein the flexible substrate (KAPTON substrate 33) is positioned directly over the base substrate (two-part epoxy bonds 38) such that a bottom surface of the flexible substrate (33) is directly adjacent to a top surface of the base substrate (38) (see, e.g., Figs. 5 and 5a, where the KAPTON substrate 33 is shown to be positioned over the two-part epoxy bonds 38).
Regarding claim 6, Eberle discloses the apparatus of claim 1. Eberle further discloses wherein the plurality of control circuits (integrated circuit chips 6) is positioned directly over the flexible substrate (KAPTON substrate 33) such that a bottom surface of the plurality of control circuits (6) is directly adjacent to a top surface of the flexible substrate (33) (see, e.g., Figs. 5 and 5a, where the integrated circuit chips 6 are shown to be positioned over each of the two-part epoxy bonds 38 and the KAPTON substrate 33).
Regarding claim 7, Eberle discloses the apparatus of claim 1. Eberle further discloses wherein the plurality of control circuits (integrated circuit chips 6) is positioned directly over a proximal portion of the flexible substrate (KAPTON substrate 33), and wherein the transducer array (transducer elements 8) is positioned directly under a distal portion of the flexible substrate (33) (see, e.g., Figs. 5 and 5a, where the integrated circuit chips 6 are shown to be positioned at the proximal end portion of the KAPTON substrate 33 and the flex circuit 2, and where the transducer elements 8 are shown to be positioned at the distal end portion of the KAPTON substrate 33 and the flex circuit 2).
Regarding claim 8, Eberle discloses the apparatus of claim 13. Eberle further discloses wherein the base substrate (two-part epoxy bonds 38) comprises a plurality of base substrate segments that are spaced apart from one another (see, e.g., Col. 9, lines 36-37, “Two-part epoxy 38 bonds the integrated circuit chips 6 to the flex circuit 2”, and Fig. 5, where there are two distinct/different epoxy bonds 38 that are shown to be positioned on either side of the integrated circuit chip 6 while being spaced apart from one another in the longitudinal direction, and where each of the integrated circuit chips 6 are shown to be spaced apart from one another in the lateral direction, such that the epoxy bonds 38 for each integrated circuit chip 6 are also spaced apart from one another in the lateral direction).
Regarding claim 9, Eberle discloses the apparatus of claim 8. Eberle further discloses wherein the plurality of base substrate segments (two-part epoxy bonds 38) are spaced apart from one another in a lateral direction (see, e.g., Col. 9, lines 36-37, “Two-part epoxy 38 bonds the integrated circuit chips 6 to the flex circuit 2”, and Figs. 1, 3, and 5, where each of the integrated circuit chips 6 are shown to be spaced apart from one another in the lateral direction, and where each of the integrated circuit chips 6 are bonded to the flex circuit 2 by the corresponding epoxy bonds 38, such that the epoxy bonds 38 for each integrated circuit chip 6 are also spaced apart from one another in the lateral direction), and wherein the transducer array (transducer elements 8, transducer portion 12) and the plurality of control circuits (integrated circuit chips 6, electronics portion 14) are spaced apart from one another in a longitudinal direction perpendicular to the lateral direction (see, e.g., Col. 3, lines 3-6, “An ultrasound transducer array and integrated circuitry are attached during fabrication of the ultrasound transducer assembly while the flexible substrate is substantially planar (i.e., flat)”, and Col. 5, lines 9-13, “The interconnection circuitry comprises conductor lines deposited upon the surface of the flex circuit 2 between a set of five (5) integrated circuit chips 6 and a set of sixty-four (64) transducer elements 8 made from PZT or PZT composites”, and Col. 9, lines 10-19, “Turning now to FIGS. 5 and 5a, a cross-sectional view and enlarged partial cross-sectional view are provided of the ultrasound transducer assembly illustrated in FIG. 2 sectioned along line 5--5 and running along the length of the ultrasound transducer assembly embodying the present invention. A KAPTON substrate 33 portion of the flex circuit 2, approximately 13 .mu.m in thickness, completely surrounds the ultrasound transducer assembly, acts as an acoustic matching layer and protects the electronic components of the ultrasound transducer assembly”, and Figs. 1-2, 5, and 5a, where the integrated circuit chips 6 are shown to be positioned at the proximal end portion of the KAPTON substrate 33 and the flex circuit 2, and where the transducer elements 8 are shown to be positioned at the distal end portion of the KAPTON substrate 33 and the flex circuit 2).
Regarding claim 10, Eberle discloses the apparatus of claim 8. Eberle further discloses wherein the flexible substrate (KAPTON substrate 33) is continuous in regions where the plurality of base substrate segments (two-part epoxy bonds 38) is spaced apart from one another (see, e.g., Col. 4, lines 65-67, “The flex circuit 2 preferably comprises a flexible polyimide film layer (substrate) such as KAPTON.TM. by DuPont”, and Col. 9, lines 10-19, “Turning now to FIGS. 5 and 5a, a cross-sectional view and enlarged partial cross-sectional view are provided of the ultrasound transducer assembly illustrated in FIG. 2 sectioned along line 5--5 and running along the length of the ultrasound transducer assembly embodying the present invention. A KAPTON substrate 33 portion of the flex circuit 2, approximately 13 .mu.m in thickness, completely surrounds the ultrasound transducer assembly, acts as an acoustic matching layer and protects the electronic components of the ultrasound transducer assembly”, and Col. 9, lines 36-37, “Two-part epoxy 38 bonds the integrated circuit chips 6 to the flex circuit 2”, and Figs. 1-2, 5, and 5a, where there are two distinct/different epoxy bonds 38 that are shown to be positioned on either side of the integrated circuit chip 6 while being spaced apart from one another in the longitudinal direction, and where each of the integrated circuit chips 6 are shown to be spaced apart from one another in the lateral direction, such that the epoxy bonds 38 for each integrated circuit chip 6 are also spaced apart from one another in the lateral direction, and where the KAPTON substrate 33 and the flex circuit 2 are shown to be one continuous substrate layer).
Regarding claim 13, Eberle discloses the apparatus of claim 1. Eberle further discloses wherein the flexible assembly (flex circuit 2) comprises further a base substrate (two-part epoxy bonds 38) (see, e.g., Fig. 5, and Col. 9, lines 36-37, “Two-part epoxy 38 bonds the integrated circuit chips 6 to the flex circuit 2”), and wherein the base substrate (38), the flexible substrate (KAPTON substrate 33), and the plurality of control circuits (integrated circuit chips 6) are distinct from one another (see, e.g., Figs. 5 and 5a, where the integrated circuit chips 6 are shown to be positioned over each of the two-part epoxy bonds 38 and the KAPTON substrate 33, and where the KAPTON substrate 33 is shown to be positioned over the two-part epoxy bonds 38).
Regarding claim 14, Eberle discloses the apparatus of claim 13. Eberle further discloses wherein the plurality of control circuits (integrated circuit chips 6) is positioned over the flexible substrate (KAPTON substrate 33) and the base substrate (two-part epoxy bonds 38), and wherein the flexible substrate (33) is positioned between the base substrate (38) and the plurality of control circuits (6) (see, e.g., Figs. 5 and 5a, where the integrated circuit chips 6 are shown to be positioned over each of the two-part epoxy bonds 38 and the KAPTON substrate 33, and where the KAPTON substrate 33 is shown to be positioned over the two-part epoxy bonds 38).
Regarding claim 15, Eberle discloses the apparatus of claim 1. Eberle further discloses wherein each recessed surface of the plurality of recessed surfaces comprises a planar surface with a rectangle shape (see, e.g., Col. 6, lines 66-67 and Col. 7, lines 1-25, “Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30. In contrast to earlier ultrasound catheter assembly designs including a relatively hard carrier material such as a rigid encapsulating epoxy, the backing material 30 that fills the spaces between the lumen tube 18 and the integrated circuit chips 6 is relatively soft. […] The backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18. While relatively soft, the backing material 30 provides a satisfactory measure of structural support to the integrated circuit chips 6 in the final assembly of the ultrasound transducer assembly”, and Figs. 3 and 5, where the integrated circuit chips 6 are shown to be positioned/received within the recessed/cavity sections (i.e., five cavities as shown in Fig. 3) of the backing material 30, such that the shape of each recessed/cavity section is formed to the shape of the respective integrated circuit chip 6, which is a rectangular shape having planar surfaces).
Regarding claim 16, Eberle discloses the apparatus of claim 1. Eberle further discloses wherein the outer profile comprises a plurality of perimeter portions of the support member (lumen tube 18 and backing material 30) positioned between the plurality of recessed surfaces, and wherein the plurality of perimeter portions is positioned radially outward of the plurality of recessed surfaces (see, e.g., Col. 6, lines 66-67 and Col. 7, lines 1-25, “Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30. In contrast to earlier ultrasound catheter assembly designs including a relatively hard carrier material such as a rigid encapsulating epoxy, the backing material 30 that fills the spaces between the lumen tube 18 and the integrated circuit chips 6 is relatively soft. […] The backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18. While relatively soft, the backing material 30 provides a satisfactory measure of structural support to the integrated circuit chips 6 in the final assembly of the ultrasound transducer assembly”, and Fig. 3, where the integrated circuit chips 6 are shown to be positioned/received within the recessed/cavity sections (i.e., five cavities as shown in Fig. 3) of the backing material 30, such that in between each of the integrated circuit chip 6 received within the recessed/cavity sections are respective corner sections of the backing material 30 that are positioned at the outer surface/profile/perimeter adjacent to the flex circuit 2).
Regarding claim 17, Eberle discloses the apparatus of claim 16. Eberle further discloses wherein the plurality of recessed surfaces comprises four recessed surfaces such that the support member (lumen tube 18 and backing material 30) comprises a square shape, and wherein the plurality of perimeter portions comprises four corners of the square shape (see, e.g., Col. 6, lines 38-48, “An electronics portion 14 of the ultrasound transducer assembly is not constrained to any particular shape. However, in the illustrative example the portions of the flex circuit 2 supporting the integrated circuit chips 6 are relatively flat as a result of the electrical connections between the flex circuit 2 and the integrated circuit chips 6. Thus the portion of the flex circuit 2 carrying five (5) integrated circuit chips 6 has a pentagon cross-section when re-shaped (wrapped) into a cylinder. In an alternative embodiment of the present invention, a re-shaped flex circuit having four (4) integrated circuits has a rectangular cross-section”, and Fig. 3, where the integrated circuit chips 6 are shown to be positioned/received within the recessed/cavity sections (i.e., five cavities as shown in Fig. 3, but can be four cavities as taught in Col. 6, lines 38-48) of the backing material 30, such that in between each of the integrated circuit chip 6 received within the recessed/cavity sections are respective corner sections of the backing material 30 that are positioned at the outer surface/profile/perimeter adjacent to the flex circuit 2).
Regarding claim 18, Eberle discloses the apparatus of claim 1. Eberle further discloses wherein the support member (lumen tube 18 and backing material 30) comprises a proximal region and a distal region, wherein the proximal region comprises the plurality of recessed surfaces, wherein the distal region comprises a circular shape (circular outline 26), and wherein the flexible assembly (flex circuit 2) is wrapped around the support member (18, 30) such that the transducer array (transducer elements 8, transducer portion 12) is positioned around the circular shape (26) (see, e.g., Col. 7, lines 14-42, “Turning now to FIG. 3, a cross-section view is provided of the ultrasound transducer assembly taken along line 3--3 and looking toward the transducer portion 12 in FIG. 2. The outside of the electronics portion 14 has a pentagon shape. The circular outline 26 represents the outside of the transducer portion 12. The flex circuit 2 encompasses the cylindrically shaped ultrasound transducer assembly. The backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18. While relatively soft, the backing material 30 provides a satisfactory measure of structural support to the integrated circuit chips 6 in the final assembly of the ultrasound transducer assembly. […] Turning now to FIG. 4, a view is provided of a cross-section of the ultrasound transducer assembly taken along line 4--4 and looking toward the electronics portion 14 in FIG. 2. The five corners of the pentagon outline comprising the electronics portion 14 are illustrated in the background of the cross-sectional view at line 4--4. The set of sixty-four (64) transducer elements 8 are displayed in the foreground of this cross-sectional view of the transducer portion 12 of the ultrasound transducer assembly. The backing material 30, characterized by relatively low acoustic impedance, fills the space between the lumen tube 18 and the transducer elements 8 as well as the gaps between adjacent ones of the sixty-four (64) transducer elements 8”, and Figs. 2-4, where the transducer elements 8, transducer portion 12 are shown to be positioned at the distal region of the lumen tube 18/backing material 30 and forms a circular shape when wrapped as shown in the bottom section of Fig. 2 and in Fig. 4, and where the integrated circuit chips 6 received within the recessed/cavity sections are shown to be positioned at the proximal region of the lumen tube 18/backing material 30 and forms a pentagon or rectangular (non-circular) shape when wrapped as shown in the top section of Fig. 2 and in Fig. 3).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Eberle (US Patent No. 5,857,974 A), as applied to claims 1 and 13 above, in view of Millett et al. (US 2014/0180143 A1, of record, cited in the Applicant’s IDS filed on 04/12/2024, hereinafter Millett).
Regarding claim 12, Eberle discloses the apparatus of claim 13. Eberle discloses the base substrate (two-part epoxy bonds 38), the flexible substrate (KAPTON substrate 33), and the plurality of control circuits (integrated circuit chips 6), and wherein the plurality of control circuits (6) comprises a plurality of integrated circuits (see, e.g., Figs. 1-5 and 5a, and Col. 3, lines 3-6, “An ultrasound transducer array and integrated circuitry are attached during fabrication of the ultrasound transducer assembly while the flexible substrate is substantially planar (i.e., flat)”, and Col. 5, lines 9-13, “The interconnection circuitry comprises conductor lines deposited upon the surface of the flex circuit 2 between a set of five (5) integrated circuit chips 6 and a set of sixty-four (64) transducer elements 8 made from PZT or PZT composites”, and Col. 9, lines 10-19, “Turning now to FIGS. 5 and 5a, a cross-sectional view and enlarged partial cross-sectional view are provided of the ultrasound transducer assembly illustrated in FIG. 2 sectioned along line 5--5 and running along the length of the ultrasound transducer assembly embodying the present invention. A KAPTON substrate 33 portion of the flex circuit 2, approximately 13 .mu.m in thickness, completely surrounds the ultrasound transducer assembly, acts as an acoustic matching layer and protects the electronic components of the ultrasound transducer assembly”, and Col. 9, lines 36-37, “Two-part epoxy 38 bonds the integrated circuit chips 6 to the flex circuit 2”).
Eberle does not specifically disclose wherein the base substrate comprises silicon, wherein the flexible substrate comprises a polymer, and wherein the plurality of control circuits comprises a plurality of application specific integrated circuits (ASICs).
However, in the same field of endeavor of intravascular devices, Millett discloses wherein the base substrate comprises silicon (see, e.g., Para. [0045], “In some embodiments, sensor structure 108 may be glued to core member 135 using an adhesive or glue. In some embodiments, the adhesive may be urethane acrylate, cyanoacrylate, silicone, epoxy, and/or combinations thereof; the adhesive is selected to secure sensor structure 108 to core member 135”, where the bonding adhesive material can comprise of silicone), wherein the flexible substrate comprises a polymer (see, e.g., Para. [0035], “In some particular embodiments, the housing containing the sensor structure is positioned between two flexible members (e.g., coils, polymer tubes, coil-embedded polymer tubes, and/or combinations thereof)”, and Para. [0058], “In step 780 the elongated substrate is bonded to the core member or other structure of the intravascular device. Accordingly, step 780 may include bonding a distal surface in the core member to a proximal surface in the elongated substrate using an adhesive. The proximal surface in the elongated substrate may be the back substrate having bonds to the electrodes as in step 770. In some instances, the elongated substrate is bonded to a component or components of the intravascular device other than the core member, such as a housing, a flexible element (e.g., coil, polymer tubing, coil-embedded polymer tubing, etc.), or otherwise”, where the flexible member layers can comprise polymer tubes), and wherein the plurality of control circuits comprises a plurality of application specific integrated circuits (ASICs) (see, e.g., Fig. 1, and Para. [0030], “Referring now to FIG. 1, shown therein is a portion of an intravascular device 100 according to an embodiment of the present disclosure. In that regard, the intravascular device 100 includes a flexible elongate member 102 having a distal portion 104 adjacent a distal end 105 and a proximal portion 106 adjacent a proximal end 107. A component 108 is positioned within the distal portion 104 of the flexible elongate member 102 proximal of the distal tip 105. Generally, the component 108 is representative of one or more electrical, electronic, optical, or electro-optical components. In that regard, the component 108 is […] an ASIC”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Eberle by including wherein the base substrate comprises silicon, wherein the flexible substrate comprises a polymer, and wherein the plurality of control circuits comprises a plurality of application specific integrated circuits (ASICs), as disclosed by Millett. One of ordinary skill in the art would have been motivated to make this modification in order to improve quality of life for the patient and reduce healthcare costs for society by treating heart disease when guided by improved diagnostic devices/methods, as recognized by Millett (see, e.g., Para. [0003]).
Allowable Subject Matter
Claim 11 is 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.
The following is a statement of reasons for the indication of allowable subject matter:
As set forth above, Eberle represents the closest prior art of record to claim 8. Claim 11 depends from claim 8. However, Eberle does not disclose or render obvious the following limitations as recited in claim 11: “wherein a quantity of the plurality of base substrate segments matches a quantity of the plurality of control circuits such that one control circuit of the plurality of control circuits is positioned over one base substrate segment of the plurality of base substrate segments”, in combination with the other claimed elements. Furthermore, there is no other prior art of record outside of Eberle that discloses or renders obvious claim 11.
Response to Arguments
Applicant's arguments, see Remarks filed 08/04/2025, have been fully considered but they are not persuasive.
Regarding Eberle (US Patent No. 5,857,974 A), Applicant argues that “Eberle does not accurately disclose each and every claimed feature as arranged in the claim” because “the presently claimed "singular rigid support member" and "backing material that ... is relatively soft" of Eberle cannot logically be the same” and “Eberle describes performing "a molding process" which is different from "the plurality of control circuits [being] positioned and received within the plurality of recessed surfaces."”, as set forth in pages 7-8 of the Remarks filed on 08/04/2025.
Examiner respectfully disagrees and emphasizes that Eberle does disclose each and every feature of amended independent claim 1, as set forth above. Specifically, Examiner emphasizes that Eberle discloses:
[1] a singular rigid support member (lumen tube 18) (see, e.g., Col. 6, lines 51-67 and Col. 7, lines 1-2, “A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium. The radiopaque material assists in locating the ultrasound transducer assembly within the body during a medical procedure incorporating the use of the ultrasound transducer assembly. As will be explained further below, the conductive property of the lumen tube 18 offers a means for connecting the transducer ground electrodes to a ground wire included in at least one of the wires connected to the cable pads 10. Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30”, where the disclose lumen tube 18 is taught to be a singular tube made of a thin radiopaque, conductive material such as Platinum/Iridium, such that the materials platinum and iridium are known in the art to be relatively stiff/hard/rigid materials) comprising an outer profile (surface profile of backing material 30) and a plurality of recessed surfaces that are recessed relative to the outer profile (see, e.g., Col. 6, lines 51-67 and Col. 7, lines 1-25, “A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium. […] Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30. […] Turning now to FIG. 3, a cross-section view is provided of the ultrasound transducer assembly taken along line 3--3 and looking toward the transducer portion 12 in FIG. 2. The outside of the electronics portion 14 has a pentagon shape. The circular outline 26 represents the outside of the transducer portion 12. The flex circuit 2 encompasses the cylindrically shaped ultrasound transducer assembly. The backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18. While relatively soft, the backing material 30 provides a satisfactory measure of structural support to the integrated circuit chips 6 in the final assembly of the ultrasound transducer assembly”, and Figs. 3 and 5, where backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18, and where the outer profile/surface of the backing material 30 is shown to be the surface adjacent to the inner side of the flex circuit 2, and where the backing material 30 is shown to comprise recessed/cavity sections (i.e., five cavities as shown in Fig. 3) where the integrated circuit chips 6 are shown to be positioned/received within, such that the recessed/cavity sections are positioned recessed relative to the outer profile/surface of the backing material); and
[2] wherein the flexible assembly (2) is wrapped around the support member (18) (see, e.g., Col. 6, lines 51-58, “FIG. 2 also shows the set of cable pads 10 on the flex circuit 2 extending from the portion of the flex circuit 2 supporting the integrated circuit chips 6. A lumen 16 in the center of the ultrasound transducer assembly (within which a guidewire is threaded during the use of a catheter upon which the transducer assembly has been mounted) is defined by a lumen tube 18 made of a thin radiopaque, conductive material such as Platinum/Iridium”, and Figs. 2-5, where the flex circuit 2 is shown to be positioned over/wrapped around the lumen tube 18 and the backing material 30) such that the plurality of control circuits (6) is positioned and received within the plurality of recessed surfaces (see, e.g., Col. 6, lines 66-67 and Col. 7, lines 1-25, “Spaces in the re-formed ultrasound transducer assembly between the integrated circuit chips 6, the transducer elements 8 and the lumen tube 18 are filled with a backing material 30. In contrast to earlier ultrasound catheter assembly designs including a relatively hard carrier material such as a rigid encapsulating epoxy, the backing material 30 that fills the spaces between the lumen tube 18 and the integrated circuit chips 6 is relatively soft. […] The backing material 30 fills the spaces between the integrated circuit chips 6 and the lumen tube 18. While relatively soft, the backing material 30 provides a satisfactory measure of structural support to the integrated circuit chips 6 in the final assembly of the ultrasound transducer assembly”, and Figs. 3 and 5, where the integrated circuit chips 6 are shown to be positioned/received within the recessed/cavity sections (i.e., five cavities as shown in Fig. 3) of the backing material 30).
Therefore, Eberle does disclose each and every feature of amended independent claim 1, as set forth above.
Conclusion
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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