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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 30 Jun 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see pg. 7, filed 30 Jun 2026, with respect to the drawing objection have been fully considered and are persuasive. The drawing objection of 07 Apr 2026 has been withdrawn in view of the amended drawings.
Applicant’s arguments, see pg. 7, filed 30 Jun 2026, with respect to the claim objection have been fully considered and are persuasive. The claim objection of 07 Apr 2026 has been withdrawn in view of the amended claim 3.
Applicant’s arguments, see pg. 7, filed 30 Jun 2026, with respect to the 35 U.S.C. 112(a) rejection have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejection of 07 Apr 2026 has been withdrawn in view of the amended claim 4.
Applicant’s arguments, see pg. 8, filed 30 Jun 2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of 07 Apr 2026 have been withdrawn in view of the amended claims.
Applicant's arguments, see pg. 8-10, filed 30 Jun 2026, with respect to the 35 U.S.C. 102 and 103 rejections have been fully considered but they are not persuasive.
Regarding independent claim 2, Applicant first argues, see pg. 8-9, that “Henneken contains no disclosure of a planar configuration in which the transducer and the ASIC/capacitor are on opposite sides of a longitudinal axis of a single substrate, nor of folding that single substrate to bring the transducer over the components”. However, the Examiner respectfully disagrees. The claim does not recite that the first and second sides of the longitudinal axis are on opposite sides. Thus, the first and second sides of the longitudinal axis have been given a broadest reasonable interpretation to include Henneken’s flexible polymer assembly 150 that comprises the ultrasound transducer substrate island or chip 110 on one side (which also will remain un-folded in the folded configuration) and the active components 132, plurality of support substrate islands or chips 140, and contact substrate island or chip 120 on another side (which also will be folded in the folded configuration). See the 35 U.S.C. 102 rejection to claim 2 below.
Applicant secondly argues, see pg. 9, that “Henneken does not disclose an adhesive bond that maintains the substrate in the folded configuration … The thermos-compression bonding described in Henneken [0063] secures the discrete active and passive components to the flexible polymer assembly”. However, the Examiner respectfully disagrees. Henneken further discloses in [0063] that neighboring support substrate islands or chips 140 are secured to each other using a suitable adhesive, and the support substrate islands or chips 140 act as rigid support members of the ultrasound transducer assembly 600 that help to give the ultrasound transducer assembly 600 its desired rigidity. Thus, for neighboring support substrate islands or chips 140 that are spaced apart in the planar configuration (see Fig. 7 of Henneken) to be secured to each other using an adhesive, or be bonded together, the flexible polymer assembly 150 must be maintained in the folded configuration via the adhesive bonding the support substrate islands or chips 140 to each other (see Fig. 8 of Henneken). See the 35 U.S.C. 102 rejection to claim 2 below.
Regarding dependent claims 3-11, Applicant argues, see pg. 9-10, that since claim 2 is patentable over Henneken, the dependent claims are also patentable. However, the Examiner respectfully disagrees at least for the reasons explained above for independent claim 2 in view of Henneken. Also see the 35 U.S.C. 102 and 103 rejections to the dependent claims below.
Status of Claims
Claims 2-20 are currently under examination. No claim has been added, cancelled, nor withdrawn since the Non-Final Office Action of 07 Apr 2026.
Drawings
The drawings were received on 30 Jun 2026. These drawings are acceptable.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation “wherein the substrate maintains spatial positioning of the ultrasonic transducer over the at least one ASIC chip and the at least one capacitor using an adhesive bond, the adhesive bond comprising an electrically insulative adhesive, and wherein the folded configuration comprises a V-shape or U-shape configuration of the substrate”. It is unclear whether “an adhesive bond” in the limitation is the same or different from “an adhesive bond” recited in claim 2, to which claim 11 depends. Consequently, the antecedent basis for “the adhesive bond” in the limitation is unclear between “an adhesive bond” recited in claim 2 and “an adhesive bond” recited in the same limitation in claim 11. For purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the substrate maintains spatial positioning of the ultrasonic transducer over the at least one ASIC chip and the at least one capacitor using the adhesive bond, the adhesive bond comprising an electrically insulative adhesive, and wherein the folded configuration comprises a V-shape or U-shape configuration of the substrate”.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-7 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henneken et al. (US PG Pub No. 2017/0209898) – hereinafter referred to as Henneken.
Regarding claim 2, Henneken discloses a transducer assembly (at least Fig. 7-8) comprising:
an ultrasonic transducer (Fig. 7-8 and [0062]: ultrasonic transducer substrate islands or chips 110);
at least one application-specific integrated circuit (ASIC) chip (Fig. 7-8 and [0064]: active components 132 such as ASICs);
at least one capacitor (Fig. 7-8 and [0064]: passive components 134, e.g., decoupling capacitors); and
a substrate (Fig. 7-8 and [0063]: flexible polymer assembly 150) having a width, a length, and a longitudinal axis extending the length of the substrate bisecting the width (see annotated Fig. 8 below):
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the substrate being foldable from a planar configuration to a folded configuration (Fig. 7: planar configuration of the flexible polymer assembly 150) and a folded configuration (Fig. 8: folded configuration of the flexible polymer assembly 150);
wherein, in the planar configuration (Fig. 7), the ultrasonic transducer (Fig. 7 and [0062]: ultrasonic transducer substrate islands or chips 110) is positioned along the width of the substrate on a first side of the longitudinal axis (see annotated Fig. 7 below: “first side” being side of flexible polymer assembly 150 onto which ultrasonic transducer substrate islands or chips 110 is attached and backing member 610 will attach as well as the side that will not be folded in the folded configuration (see Fig. 8)), and the at least one ASIC chip (Fig. 7 and [0064]: active components 132 such as ASICs) and the at least one capacitor (Fig. 7 and [0064]: passive components 134, e.g., decoupling capacitors) are positioned side-by-side along a second side of the longitudinal axis (see annotated Fig. 7 below: “second side” being side of flexible polymer assembly 150 onto which active components 132, plurality of support substrate islands or chips 140, and contact substrate island or chip 120 are attached as well as the side that will be folded in the folded configuration (see Fig. 8)):
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wherein, in the folded configuration (Fig. 8), the ultrasonic transducer (Fig. 8 and [0062]: ultrasonic transducer substrate islands or chips 110) is positioned over (see annotated Fig. 8 below) and in electrical communication with the at least one ASIC chip (Fig. 8 and [0064]: active components 132 such as ASICs) and the at least one capacitor (Fig. 8 and [0064]: passive components 134, e.g., decoupling capacitors; [0054]: ultrasound transducer substrate chips 110 electrically connected to active components 132 and passive components 134):
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wherein an adhesive bond maintains the substrate in the folded configuration ([0064]: active components 132 and passive components 134 thermo compression bonded to flexible polymer assembly 150; [0063]: neighbouring support substrate islands or chips 140 secured to each other using a suitable adhesive, and the support substrate islands or chips 140 act as rigid support members of the ultrasound transducer assembly 600 that help to give the ultrasound transducer assembly 600 its desired rigidity; [0065]: ultrasound transducer substrate chip 110 and substrate island affixed to backing member 610 using an adhesive).
As noted above in the Response to Arguments, Henneken discloses support substrate islands or chips 140 that are spaced apart in the planar configuration (see Fig. 7 of Henneken) to be secured to each other using an adhesive, or be bonded together, that the flexible polymer assembly 150 must be maintained in the folded configuration via the adhesive bonding the support substrate islands or chips 140 to each other (see Fig. 8 of Henneken).
Regarding claim 3, Henneken discloses all limitations of claim 2, as discussed above, and Henneken further discloses:
wherein the ultrasonic transducer (Fig. 7-9: ultrasonic transducer substrate islands or chips 110) comprises a plurality of drums arranged in linear elements ([0048]: ultrasonic transducer chips 110 includes a plurality of capacitive micro-machined ultrasonic transducer (CMUT) elements; Fig. 91-f and [0067]: ultrasonic transducer elements 112 of ultrasonic transducer substrate islands or chips 110 arranged linearly).
As evidenced by Wittingham et al. (Wittingham et al. “Transducers and beam forming” in Diagnostic Ultrasound Physics and Equipment by Hoskins et al. (2019). 3: 44-46. DOI: 10.1201/9781138893603. A copy previously provided in the Non-Final Office Action of 07 Apr 2026.), CMUT is well known in the art to comprise transducer elements in a drum structure (see pg. 45 of Wittingham et al.).
Regarding claim 4, Henneken discloses all limitations of claim 3, as discussed above, and Henneken further discloses:
wherein each linear element of the ultrasonic transducer comprises between 16 and 32 drums (Fig. 9a: up to 5X10 or 50 drums/elements 112 vertically in each linear arrangement).
Regarding claim 5, Henneken discloses all limitations of claim 3, as discussed above, and Henneken further discloses:
wherein each linear element of the ultrasonic transducer (Fig. 9: ultrasonic transducer elements 112 of ultrasonic transducer substrate islands or chips 110) includes a solder point at each end (Fig. 9: first contacts 114 at each end of transducer elements 112 arranged horizontally), wherein a tracer electrically connects the linear element to the at least one ASIC chip (Fig. 7-9 and [0068]: first contacts 114 connected to second contacts 122 by flexible polymer assembly 150; [0050], [0060]: flexible polymer assembly 150 electrically connects transducer chips 110 to contact chip 120 through active components (ASICs) 132).
Regarding claim 6, Henneken discloses all limitations of claim 5, as discussed above, and Henneken further discloses:
wherein at least one ASIC chip (Fig. 7-8 and [0064]: active components 132 such as ASICs) is configured to control up to 16 linear elements of the ultrasonic transducer (Fig. 9: up to 20 linearly arranged elements 112; [0054]: active components (ASICs) 132 are transducer controllers; [0009]: ASCs provide the ultrasound transducer with control signals).
Regarding claim 7, Henneken discloses all limitations of claim 2, as discussed above, and Henneken further discloses:
wherein the ultrasonic transducer (Fig. 7-8 and [0062]: ultrasonic transducer substrate islands or chips 110), the at least one ASIC chip (Fig. 7-8 and [0064]: active components 132 such as ASICs), and the at least one capacitor (Fig. 7-8 and [0064]: passive components 134, e.g., decoupling capacitors) are in electronic communication with each other via traces etched into the substrate or via vias through the substrate ([0050]: flexible polymer assembly 150 include embedded conductive tracks between ultrasound transducer chips 110 and contact chip 120/220 for engaging with coaxial wire assembly 200; [0060]: flexible polymer assembly 150 extend along an outer side of the backing member 610, such that the transducer chips 110 and the contact ship 120 are electrically interconnected through active and passive components 132, 134, respectively).
Regarding claim 10, Henneken discloses all limitations of claim 2, as discussed above, and Henneken further discloses:
wherein positioning of the at least one ASIC chip (Fig. 7-8 and [0064]: active components 132 such as ASICs), the ultrasonic transducer (Fig. 7-8 and [0062]: ultrasonic transducer substrate islands or chips 110), and the at least one capacitor (Fig. 7-8 and [0064]: passive components 134, e.g., decoupling capacitors) creates a compact configuration that enables the transducer assembly to be positioned within a distal tip of a catheter (Fig. 7-8 and [0016]: present invention for a particularly compact transducer assembly used in a catheter capable of acquiring high resolution ultrasound images in a forward looking direction, or at distal tip of the catheter).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Henneken, as applied to claim 2 above, and further in view of Cuscuna (US PG Pub No. 2018/0271494).
Regarding claim 8, Henneken discloses all limitations of claim 2, as discussed above, and Henneken does not disclose:
an interposer, the interposer comprising a plurality of electrical connections and wires that extend from the handle assembly to the transducer assembly.
In the same field of ultrasound probe comprising a transducer with electrical connections, Cuscuna, however, teaches:
an interposer (Fig. 1C, 2B, 5: interposer 330), the interposer (interposer 330) comprising a plurality of electrical connections and wires (Fig. 1C, 2B, 5; [0029]-[0030]: interposer 330 includes conductors 335 electrically coupled to conductors of flexible circuit 325 and printed circuit board (PCB) 435; [0024]: flexible circuit 325 includes an insulating polymer film with conductive elements (e.g., wires) applied on one surface) that extend from the handle assembly (Fig. 8: probe handle 14) to the transducer assembly (Fig. 8: probe 12; Fig. 8 and [0041]: probe 12 comprising interposer 330 electrically coupled to electronic box via cable 16 and connector 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Henneken’s catheter to include Cuscuna’s interposer. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., adding an interposer, as disclosed by Cuscuna), and the combination would have yielded a reasonable expectation of success, since both Henneken and Cuscuna are directed an ultrasound probe comprising a transducer with electrical connections. The motivation for the combination is to “provide more reliable electrical coupling and easier disassembly” ([0024] of Cuscuna) among the components connected to the ultrasound transducer while allowing these components be upgraded and/or replaced rather than replacing the entire transducer assembly ([0024] of Cuscuna).
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Henneken in view of Cuscuna, as applied to claim 8 above, and further in view of Lee et al. (US PG Pub No. 2020/0009615) – hereinafter referred to as Lee.
Regarding claim 9, Henneken in view of Cuscuna discloses all limitations of claim 8, as discussed above, and Henneken in view of Cuscuna does not disclose:
wherein the interposer is a ribbon structure having a distal portion connected to the transducer assembly at a connection pad, and a proximal portion split into a right side portion and a left side portion, the right side portion and the left side portion wrapping around and above a working channel of a catheter.
In the same field of ultrasound transducer comprising a transducer with electrical connections, Lee, however, teaches:
a flexible interposer (Fig. 1: interposer 13, 16) having a distal portion connected to a transducer assembly at a connection pad (Fig. 1 and [0032]-[0033]: conductor is deposited on the interposer 13 and interposer 13 in contact with acoustic array 22; see annotated Fig. 3 below), and
a proximal portion split into a right side portion and a left side portion (Fig. 1, 3: left and right ends of interposer 13, 16 not in contact with acoustic array 22 and layers 10-12; see annotated Fig. 3 below), the right side portion and the left side portion wrapping around and above a cavity (see annotated Fig. 3 below):
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It is noted that the limitation “ribbon structure” has been given a broadest reasonable interpretation in view of [0155] of the specification of the instant application as a flexible strip capable of being folded, and Lee discloses an interposer capable of being folded (see Fig. 1 v. 3
of Lee).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Henneken in view of Cuscana to include Lee’s flexible interposer capable of being folded. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., folding interposer, as disclosed by Lee), and the combination would have yielded a reasonable expectation of success, since Henneken, Cuscana, and Lee are directed an ultrasound transducer. The motivation for the combination would have been to allow the interposer for reliable electrical coupling and easier disassembly among components of the ultrasonic transducer assembly to be “folded for fitting into a catheter” for insertion into a narrow region of interest ([0058] of Lee).
Regarding claim 11, Henneken discloses all limitations of claim 2, as discussed above, and Henneken further discloses:
wherein the substrate (Fig. 7-8 and [0063]: flexible polymer assembly 150) maintains spatial positioning of the ultrasonic transducer over the at least one ASIC chip (Fig. 7-8 and [0064]: active components 132 such as ASICs) and the at least one capacitor (Fig. 7-8 and [0064]: passive components 134, e.g., decoupling capacitors) using an adhesive bond ([0064]: active components 132 and passive components 134 thermo compression bonded to flexible polymer assembly 150),
wherein the folded configuration comprises a V-shape or U-shape configuration of the substrate (Fig. 8: flexible polymer assembly 150 comprising a plurality of U-shape folds between active and passive components 132 and 134, respectively).
Henneken does not disclose:
wherein the adhesive bond comprising an electrically insulative adhesive.
In the same field of ultrasound transducer comprising a transducer with electrical connections, Lee, however, teaches:
an adhesive bond comprising an electrically insulative adhesive ([0034]: bonding material is epoxy layer 14).
It is noted that epoxy is well known in the art to be electrically insulative.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter of Henneken in view of Cuscana to include Lee’s electrically insulative adhesive. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., bonding using an epoxy, as disclosed by Lee), and the combination would have yielded a reasonable expectation of success, since Henneken, Cuscana, and Lee are directed an ultrasound transducer. The motivation for the combination would have been to utilize a low-temperature curable polymer to avoid damaging the components of the transducer assembly during the assembly (see [0035] of Lee) as well as provide an electrical insulation to seal and protect sensitive electrical components of the transducer assembly.
Allowable Subject Matter
Claims 12-20 are allowable. See the Non-Final Office Action of 07 Apr 2026 for the reasons for the indication of allowable subject matter.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/16/26
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