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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the backing block being between the transducer array and the cable connection portion must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are 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.
Regarding claim 1, the limitation recites “the outer surface of the proximal region”. However, it is unclear if this limitation is supposed to actually be “the outer surface of the proximal region”, in which case there would be an antecedent basis issue, or if it is supposed to be “the outer surface of the flexible circuit”. For examination purposes, it shall be considered as “the outer surface of the flexible circuit”.
Regarding claim 11, the term “approximately” is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, the claim shall be considered as “The device of claim 1, wherein a length between the transducer array and the cable connection portion is between 0.85 mm and 0.95 mm, and wherein the cable connection portion has a length of 2 mm.”
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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, 9, 10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sudol (US20230052311A1) in view of Beers et al., (US20190022699A1).
Regarding claim 1, Sudol teaches an intracardiac echocardiography (“ICE”) catheter device comprising ([0005] ICE catheters):
A flexible circuit, comprising ([0049] interposer 310 may be a flexible printed circuit assembly; [0046] includes microbeam former IC 304):
an outer surface and an inner surface configured to face an opposite of the outer surface (fig. 4 the IC 304 has an upper surface facing up that would be the outer, and a lower surface that is facing down that would be the inner surface),
a distal region (see annotated fig. 4 the IC 304 to the distal end of the interposer 310)
a proximal region having a plurality of traces (fig. 6A the circuit board includes conductive traces [0055])
a transducer array positioned on the outer surface of the proximal region electrically coupled to the plurality of traces (fig. 4 transducer array is connected to the upper portion of the IC 304 and includes conductive traces formed on the surface of the interposer that facilitates electrical communication between the transducer and the IC 304 [0055]), the plurality of traces arranged to electrically couple to a plurality of transducers of the transducer array ([0055] interposer 310 is connected to the transducer array 262 through the traces);
a backing block on the inner surface opposite the transducer array (fig. 4 the backing block 410 is on the bottom (inner) surface of the IC 304);
a cable connection portion in the distal region, the cable connection portion having one or more connectors (fig. 6A the distal region 625 of the interposer has wire bondings 320);
one or more bundles positioned on the outer surface coupled to the one or more connectors in the cable connection portion, where each bundle includes a plurality of communication channels (fig. 8a - 10bconducive pads 602, 604, 606 receive cables such as 700a, 700b, and 1000 and are on the top surface of interpose 310 [0064]- [0082]).
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However, Sudol fails to teach wherein the cable portion connection portion is positioned such that a cable connection inner surface faces the backing block, and the backing block is between the transducer array and the cable connection portion.
In the same ultrasound field of endeavor, Beers teaches wherein the cable portion connection portion is positioned such that a cable connection inner surface faces the backing block (fig. 4 traces 440 are facing down on the flex circuit 404, which would face the backing block (fig.6/7 a backing black can be on the back side of the stiffener 602[0042])), and the backing block is between the transducer array and the cable connection portion (fig. 12 the backing block 1212 is between transducer array and the flex circuit when the flex circuit is folded down).
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 Sudol with the characteristics of the device of Beers, as this would facilitate maintaining performance and/maintaining manufacturability (see Beers [0026]).
Regarding claim 2, modified Sudol teaches the device of claim 1, wherein Sudol further teaches wherein the flexible circuit comprises a shield located on a portion of the flexible circuit such that the cable connection portion is between the transducer array and the shield (fig. 9A shield layer 710 is positioned around insulation layer 715, and the wire bonding 320 would be between the shield layer 710 and the transducer array).
Regarding claim 9, modified Sudol teaches the device of claim 1, but fails to explicitly disclose wherein the flexible circuit comprises a ground bar, wherein the ground bar is arranged to be at least partially around the plurality of transducer and the one or more connectors.
In the same ultrasound field of endeavor, Beers teaches wherein the flexible circuit comprises a ground bar, wherein the ground bar is arranged to be at least partially around the plurality of transducer and the one or more connectors (fig. 12 ground foil 1206 partially surrounds the active layers 1208).
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 Sudol with the characteristics of the device of Beers, as this would facilitate maintaining performance and/maintaining manufacturability (see Beers [0026]).
Regarding claim 10, modified Sudol teaches the device of claim 1, but is silent regarding wherein a subset of the plurality of traces connects to a left portion of the one or more connectors, wherein a second subset of the plurality of traces connects to a right portion of the one or more connectors.
In the same ultrasound field of endeavor, Beers teaches wherein a subset of the plurality of traces connects to a left portion of the one or more connectors, wherein a second subset of the plurality of traces connects to a right portion of the one or more connectors (see annotated 2, the subsets of traces connect to a left and right portion of the connectors).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the device of Sudol with the characteristics of the device of Beers, as this would facilitate maintaining performance and/maintaining manufacturability (see Beers [0026]).
Regarding claim 12, modified Sudol teaches the device of claim 1, wherein Sudol further teaches wherein the plurality of traces are coupled to a plurality of electrical connectors ([0055] there are a plurality of conductive traces on the interposer 310, and there would be physically coupled to the electrical connectors such as the electrical pads or the wire bonding).
Regarding claim 13, modified Sudol teaches the device of claim 1, but fails to explicitly disclose wherein an arraignment of the plurality of traces reduces a signal processing time from the one or more bundles to the plurality of transducers, wherein the arrangement of the plurality of traces extend in a non-linear path from the transducer array to the one or more connectors to improve the signal processing time.
In the same ultrasound field of endeavor, Beers teaches wherein an arraignment of the plurality of traces reduces a signal processing time from the one or more bundles to the plurality of transducers, wherein the arrangement of the plurality of traces extend in a non-linear path from the transducer array to the one or more connectors to improve the signal processing time (fig 2-5 the traces have arraignment of a non-linear path, and therefore would be capable of to improve the signal processing time).
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 Sudol with the characteristics of the device of Beers, as this would facilitate maintaining performance and/maintaining manufacturability (see Beers [0026]).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Sudol in view of Beers as applied to claim 1 above, and further in view of Dausch et al., (US20130267853A1).
Regarding claim 4, modified Sudol teaches the device of claim 1, but fails to explicitly disclose wherein each of the plurality of transducers are coupled to each of the plurality of traces, wherein the plurality of transducers include sixty-four transducers, wherein the plurality of traces include sixty-four traces.
In the same ultrasound field of endeavor Dausch teaches wherein each of the plurality of transducers are coupled to each of the plurality of traces, wherein the plurality of transducers include sixty-four transducers, wherein the plurality of traces include sixty-four traces ([0010] a flex cable with 64 elements may connect to all elements of 64 element transducer array).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of 64 transducers coupled to 64 traces of Dausch to the base device of modified Sudol, as both inventions relate to ultrasound imaging devices and would yield the predictable result of an ICE catheter device that has 64 transducer elements coupled to 64 traces to one of ordinary skill in the art. One of ordinary skill would be able to apply such an technique, and the results of the device of modified Sudol using 64 traces coupled to 64 transducer elements are reasonably predictable. This would be an improvement as this would reduce cross-coupling between channels.
Regarding claim 5, modified Sudol teaches the device of claim 4, but fails to explicitly disclose wherein one of the one or more connectors are coupled to a group of sixteen traces of the sixty-four traces of the plurality of traces.
In the same ultrasound field of endeavor, Dausch teaches wherein one of the one or more connectors are coupled to a group of sixteen traces of the sixty-four traces of the plurality of traces ([0010] the flex cable are split into 4 layers of 16 traces, as such the conductors of one layer would be coupled to 16 traces).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of layered traces of Dausch to the base device of modified Sudol, as both inventions relate to ultrasound imaging devices and would yield the predictable result of an ICE catheter device that has layered traces to one of ordinary skill in the art. One of ordinary skill would be able to apply such an technique, and the results of the device of modified Sudol using layered traces are reasonably predictable. This would be an improvement as this would support higher channel count while preserving individual element access.
Claims 6 are rejected under 35 U.S.C. 103 as being unpatentable over Sudol in view of Beers as applied to claim 1 above, and further in view of Saiga (US 20170196537 A1)
Regarding claim 6, modified Sudol teaches the device of claim 4, but fails to explicitly disclose wherein the one or more bundles are sixteen wires, wherein one of the one or more connectors is coupled to four wires of the sixteen wires.
In the same ultrasound field of endeavor, Saiga teaches wherein the one or more bundles are sixteen wires, wherein one of the one or more connectors is coupled to four wires of the sixteen wires (fig. 6 each unit is a bundle of 16 coaxial wires, and the plurality of flexible substrate are attached to the respective bundles. This mean the connector on the substrate would be coupled to at least four wires of the bundle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply wiring of Saiga to the base device of modified Sudol, as both inventions relate to ultrasound imaging devices and would yield the predictable result of an ICE catheter device that connectors that are coupled to four wires of a bundle of sixteen wires to one of ordinary skill in the art. One of ordinary skill would be able to apply such an technique, and the results of the device of modified Sudol having a connector that is coupled to four wires are reasonably predictable. This would be an improvement as this would support higher channel count while preserving individual element access.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sudol in view of Beers as applied to claim 1 above, and further in view of Lee et al., (US20020053590A1).
Regarding claim 7, modified Sudol teaches the device of claim 1, but fails to explicitly teach wherein the transducer array is distal to a cut line, wherein the flexible circuit comprises a test connection portion, wherein the test connection portion is located on one side of the cut line and the transducer array is located on an opposite side of the cut line, wherein the test connection portion includes an electrical connection to each of the plurality of transducers.
However in the same ultrasound field of endeavor, Lee teaches wherein the transducer array is distal to a cut line, wherein the flexible circuit comprises a test connection portion, wherein the test connection portion is located on one side of the cut line and the transducer array is located on an opposite side of the cut line, wherein the test connection portion includes an electrical connection to each of the plurality of transducers (fig. 31A once the testing is complete testing pad 5064 is cut away from the connection pad, and the cut is between the testing pad and the transducer [0158]).
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 Sudol with the testing of Lee, as this would ensure that the electrical connections are functional and operationally connected to the components( see Lee [0158]).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sudol in view of Beers as applied to claim 1 above, and further in view of Koduri et al., (US 20140321601 A1).
Regarding claim 8, modified Sudol teaches the device of claim 1, but fails to explicitly disclose wherein the plurality of traces has a length between 1.40 mm and 3.43 mm.
In the same imaging field of endeavor, Koduri teaches wherein the plurality of traces has a length between 1.40 mm and 3.43 mm ([0025] on the flexible printed circuit board, the circuit traces are less than 100mm).
Though Koduri does not specifically disclose that the traces has a length between 1.4mm and 3.43 mm, it would have been obvious to one of ordinary skill in the art, through routine optimization to adopt the claimed length in order to accommodate the spatial constraints of the flexible printed circuit board ( see MPEP 2144.05).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at 5712722714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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